Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181530
World Total Knee System · Signature Orthopaedics Pty, Ltd. · decided 2018-10-24 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| World Knee PS All Poly Tibia | 121-20-6709 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215116408 |
| World Knee System | 121-20-8400 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037574 |
| World Knee CR All Poly Tibia | 121-20-6919 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215116330 |
| World Knee CR All Poly Tibia | 121-20-6619 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215116309 |
| World Knee System | 121-20-0403 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037796 |
| World Knee System | 121-20-6510 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215036973 |
| World Knee System | 121-20-6102 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215036270 |
| World Knee Spherical Patella – Finned Peg | 121-20-8420 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215139179 |
| World Knee CR All Poly Tibia | 121-20-6128 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215115999 |
| World Knee System | 121-20-1611 | SIGNATURE ORTHOPAEDICS PTY LTD | MBH | 09348215035778 |
| World Knee Spherical Patella – Finned Peg Vit-E | 121-20-8620E | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215134334 |
| World Knee System | 121-20-0613 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037901 |
| World Knee System | 121-20-1912 | SIGNATURE ORTHOPAEDICS PTY LTD | MBH | 09348215035891 |
| World Knee Asymmetrical Patella – Finned Peg | 121-20-8230 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215139254 |
| World Knee Spherical Patella – Finned Peg | 121-20-8020 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215139131 |
| World Knee UC All Poly Tibia | 121-20-6438 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215116194 |
| World Knee System | 121-20-6700 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215036690 |
| World Knee Spherical Patella Vit-E | 121-20-8000E | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215134129 |
| World Knee Tibial Monotrial - UC | 122-18-0590 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215081218 |
| World Knee System | 121-20-8510 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037635 |
| World Knee System | 121-20-8200 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037550 |
| World Knee System | 121-20-6530 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215037338 |
| All Poly Monotrial UC | 122-18-0472 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215081294 |
| World Knee CR All Poly Tibia | 121-20-6918 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215116064 |
| World Knee Spherical Patella – Finned Peg Vit-E | 121-20-8922E | SIGNATURE ORTHOPAEDICS PTY LTD | JWH MBH | 09348215134266 |