Lane Cove West, AU · 26 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 7 | 2025-08-07 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 6 | 2024-11-25 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2024-09-11 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 2 | 2025-12-16 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 2 | 2025-05-12 |
| — | — | — | — | 1 | 2026-03-12 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 1 | 2025-12-23 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | 1 | 2025-05-13 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | 1 | 2024-02-13 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2020-08-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-12 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | — | — | — |
| 2025-12-23 | K253239 | Active-V Total Knee System; World Total Knee System | MBH | Class II | Orthopedic |
| 2025-12-16 | K251771 | Cambridge Partial Knee | HSX | Class II | Orthopedic |
| 2025-08-07 | K243021 | Longboard Revision Hip Stem | LZO | Class II | Orthopedic |
| 2025-05-13 | K242674 | Freedom Posterior Cervical Screws | NKG | Class II | Orthopedic |
| 2025-05-12 | K242477 | Shoulder Soft Tissue Anchors | MBI | Class II | Orthopedic |
| 2025-05-02 | K243043 | Origin Cemented Hip Stem | LZO | Class II | Orthopedic |
| 2025-03-11 | K243029 | Origin TT Stem | LZO | Class II | Orthopedic |
| 2024-11-25 | K243162 | World Liner | MEH | Class II | Orthopedic |
| 2024-09-11 | K240683 | Rx Knee System | JWH | Class II | Orthopedic |
| 2024-08-01 | K241690 | Logical Liner; World Liner; World Knee Patella | MEH | Class II | Orthopedic |
| 2024-02-13 | K231134 | VerteLoc Spinal System | MQP | Class II | Orthopedic |
| 2023-05-03 | K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | MBI | Class II | Orthopedic |
| 2023-01-13 | K220495 | SignaSure Dual Mobility System | MEH | Class II | Orthopedic |
| 2022-11-04 | K223062 | World Total Knee System | JWH | Class II | Orthopedic |
| 2022-10-04 | K222380 | TriVerse Total Knee Replacement System | JWH | Class II | Orthopedic |
| 2022-06-16 | K212870 | TLC Unicompartmental Knee System | HSX | Class II | Orthopedic |
| 2022-04-11 | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) | JWH | Class II | Orthopedic |
| 2022-01-07 | K211742 | SignaSure Dual Mobility System | MEH | Class II | Orthopedic |
| 2021-09-24 | K211505 | Encore Hip Stem | MEH | Class II | Orthopedic |
| 2021-04-16 | K201047 | Fusion Taper System | LZO | Class II | Orthopedic |
| 2020-09-21 | K201278 | World Hip Stem, World Cup, World Liner | MEH | Class II | Orthopedic |
| 2020-08-14 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | LPH | Class II | Orthopedic |
| 2020-08-05 | K192883 | Spartan Hip Stem | LZO | Class II | Orthopedic |
| 2020-07-31 | K201951 | Cemented Origin Hip Stem | LZO | Class II | Orthopedic |
| 2020-06-19 | K192024 | Cemented TSI Hip Stem | LZO | Class II | Orthopedic |