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Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022
5Authorisation
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5 Authorisation
Supply by a specified health practitioner
(1) A health practitioner specified in column 4 of an item in the table in Schedule 1 is authorised to supply a kind of medical device to a patient of that practitioner where:
(a) the kind of medical device is specified in column 2 of that item; and
(b) the supply is for the purpose specified in column 3 of that item; and
(c) the conditions specified in subsection (2) are satisfied.
(2) The health practitioner must:
(a) inform the patient, or a parent or guardian of the patient, that the kind of medical device is not included in the Register; and
(b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the kind of medical device; and
(c) supply the kind of medical device in accordance with good medical practice; and
(d) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and
(e) if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.
Supply to a patient of a specified health practitioner
(3) A health practitioner is authorised to supply a kind of medical device to a patient of a health practitioner specified in column 4 of an item in the table in Schedule 1 (the treating practitioner) where:
(a) the kind of medical device is specified in column 2 of that item; and
(b) the supply is requested by the treating practitioner; and
(c) the supply is for the purpose specified in column 3 of that item; and
(d) the conditions specified in subsection (4) are satisfied.
(4) The health practitioner supplying the medical device must:
(a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and
(b) if the health practitioner becomes aware of a defect in the kind of medical device—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.
Schedule 1—Medical devices authorised for supply
Note: See section 5.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="5" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Specified therapeutic goods</span></p></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 1</span></p></td><td style="width:28.28%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 2</span></p></td><td style="width:34.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 3</span></p></td><td style="width:23.52%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 4</span></p></td><td style="border-top:0.75pt solid #000000; vertical-align:top"></td></tr><tr style="height:2.85pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Item</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Kind of medical device</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Purpose</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:normal; font-size:10pt"><span style="font-weight:bold">Health practitioner</span></p></td><td style="vertical-align:top"></td></tr></thead><tbody><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">1</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">14/16 Taper Femoral Heads – Oxinium – Smith & Nephew (71342280 – 71342368)</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">4</span></p></td><td style="width:28.28%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">AltiVate Reverse Shoulder system – DJO Global</span></p></td><td style="width:34.9%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for arthroplasty of the shoulder</span></p></td><td style="width:23.52%; border-top:1pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">7</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">CelGro Type I/III collagen scaffold – Orthocell</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt"></span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">articular cartilage repair: collagen scaffold for use with autologous chondrocyte implantation (ACI) to knee (including patellofemoral) and ankle joint; or</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">augmentation of rotator cuff tendon repair</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">8</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">CollaCote Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">9</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">CollaPlug Absorbable Collagen Wound Dressing</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">10</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">CollaTape Absorbable Collagen</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for haemostasis or to protect the wound surface during dental procedures</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">11</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Duraloc Acetabular Cup System – Hip Insert/Liner – Johnson & Johnson t/a DePuy Synthes</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">15</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Endotine Forehead</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for use in subperiosteal browplasty surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">ophthalmologist;</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">plastic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">16</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Endotine Midface</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for use in subperiosteal midface suspension surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">plastic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">19</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Insall/Burstein II Modular Knee System - Posterior Stabilised Tibial Articular Surface – Zimmer Biomet (00522003101 – 00522003506)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">21</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">MG II Total Knee System - Tibial Articular Surface – Zimmer Biomet (00511002309 – 00511005323)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">22</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">M/G Unicompartmental Knee System - Tibial Articulating Surface – Zimmer Biomet</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">(00578804008 – 00578808014)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">23</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Natural Knee II System – Durasul PE Congruent Tibial Insert – Zimmer Biomet (620108809 – 620110916)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">24</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">NexGen Complete Knee Solution – Cruciate Retaining (CR) Articular Surface – Zimmer Biomet (00597002009 – 00597005020)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">25</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">NexGen Complete Knee Solution Legacy PS - Articular Surface – Zimmer Biomet (5996-020-09 to 00-5996-022-23 AND 00-5996-030-09 to 00-5996-051-20)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">26</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">NexGen Complete Knee Solution Mobile Bearing Knee System - Articular Surface – Zimmer Biomet (00594203109 – 00594207217)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">27</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">NexGen Complete Knee Solution – Posterior Stabilized (PS) Articular Surface – Zimmer Biomet (00598202010 – 00598205123)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision knee arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">28</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Omnifit Crossfire Series II Cup Insert – Stryker Orthopaedics (2041C2240 - 2041C3274)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">28A</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Origin Stem, Cox Vara, Sizes 9 to 18 – Signature Orthopaedics</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">29</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Primetech Piezo Micro Manipulator and microinjection pipettes</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">in vitro fertilisation</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">obstetrics and gynaecology specialist</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">30</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Pro Osteon®</span><span style="font-size:10pt"> </span><span style="font-size:10pt">Bone Graft Substitute 200R</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for use as a bone graft substitute only for bony voids or gaps that are not intrinsic to the stability of the bony structure</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">medical practitioner; dental practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">31</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Pro Osteon®</span><span style="font-size:10pt"> </span><span style="font-size:10pt">Bone Graft Substitute 500R</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for use as a bone graft substitute only for voids or gaps that are not intrinsic to the stability of the bony structure</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">medical practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">32</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Quintip Individual Skin Test System</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for allergy skin testing using puncture to apply the test extract</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">medical practitioner</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">33</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Reflection Ceramic Acetabular System - Reflection Biolox Forte Ceramic Acetabular Liner – Smith & Nephew (71338146 – 71338456)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">34</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Regeneten Bioinductive Implant – Bone Anchors with Arthroscopic Delivery System</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">rotator cuff surgery</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">35</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">SeleXys Hip System – Inlay Bionit2 – Mathys Orthopaedics (55462803 – 55463612)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">35A</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Taurolock-U25.000 ((cyclo)-taurolidine, citrate (4%) and urokinase (25.000 IU))</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">for use as a catheter lock solution, instilled into a port or a silicone or polyurethane catheter</span><span style="font-size:10pt">‑</span><span style="font-size:10pt">based device at the termination of a treatment, and is withdrawn prior to subsequent treatments</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">nephrology physician</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:1pt"><td style="width:12.88%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">36</span></p></td><td style="width:28.28%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">Trilogy AB Alternate Bearing Shell Insert – Zimmer Biomet (00640502601 – 00640503206 AND 00641502802 – 00641503206)</span></p></td><td style="width:34.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">revision hip arthroplasty</span></p></td><td style="width:23.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">orthopaedic surgeon</span></p></td><td style="vertical-align:top"></td></tr><tr style="height:0pt"><td style="width:53.55pt"></td><td style="width:117.55pt"></td><td style="width:145.05pt"></td><td style="width:97.75pt"></td><td style="width:1.75pt"></td></tr></tbody></table>