Signature Orthopaedics Pty, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 44
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | March 12, 2026 |
| K253239 | Active-V Total Knee System; World Total Knee System | December 23, 2025 |
| K251771 | Cambridge Partial Knee | December 16, 2025 |
| K243021 | Longboard Revision Hip Stem | August 7, 2025 |
| K242674 | Freedom Posterior Cervical Screws | May 13, 2025 |
| K242477 | Shoulder Soft Tissue Anchors | May 12, 2025 |
| K243043 | Origin Cemented Hip Stem | May 2, 2025 |
| K243029 | Origin TT Stem | March 11, 2025 |
| K243162 | World Liner | November 25, 2024 |
| K240683 | Rx Knee System | September 11, 2024 |
| K241690 | Logical Liner; World Liner; World Knee Patella | August 1, 2024 |
| K231134 | VerteLoc Spinal System | February 13, 2024 |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | May 3, 2023 |
| K220495 | SignaSure Dual Mobility System | January 13, 2023 |
| K223062 | World Total Knee System | November 4, 2022 |
| K222380 | TriVerse Total Knee Replacement System | October 4, 2022 |
| K212870 | TLC Unicompartmental Knee System | June 16, 2022 |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS | April 11, 2022 |
| K211742 | SignaSure Dual Mobility System | January 7, 2022 |
| K211505 | Encore Hip Stem | September 24, 2021 |