Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222380
TriVerse Total Knee Replacement System · Signature Orthopaedics Pty, Ltd. · decided 2022-10-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TriVerse AS Tibia Insert Trial, 71x11 | 122-22-6711 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215132354 |
| V2 TriVerse Femoral Cutting Block | 122-22-4375 | SIGNATURE ORTHOPAEDICS PTY LTD | MDM | 09348215128357 |
| TriVerse Meniscal Insert PS+ | 121-27-8071 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215107888 |
| TriVerse Meniscal Insert CR | 121-27-4715 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215103712 |
| TriVerse Meniscal Insert AS | 02-032-51-7120 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215102203 |
| TriVerse Meniscal Insert AS | 02-032-51-6716 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215102104 |
| TriVerse Meniscal Insert AS | 02-032-51-7914 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215101701 |
| TriVerse Modular I-Beam | 121-27-0020 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215101091 |
| TriVerse Modular Tray Trial | 122-22-3079 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215097691 |
| TriVerse Asymmetric Patella Trial | 122-22-3162 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215097608 |
| Triverse Tibia Insert Trial Combo, 63-67x14 | 122-22-8374 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215128548 |
| TriVerse Meniscal Insert PS+ | 121-27-8459 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215108021 |
| TriVerse Meniscal Insert PS+ | 121-27-8479 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215107956 |
| TriVerse Meniscal Insert PS+ | 02-032-44-7124 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215104979 |
| TriVerse Meniscal Insert CR | 02-032-47-7113 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215103682 |
| TriVerse Meniscal Insert CR | 02-032-47-7112 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215103668 |
| TriVerse Meniscal Insert AS | 02-032-51-5911 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215101886 |
| TriVerse Meniscal Insert AS | 121-27-6715 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215101473 |
| TriVerse Modular Tray | 121-27-0267 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215100919 |
| TriVerse Tibial Insert Trial | 02-039-47-5910 | SIGNATURE ORTHOPAEDICS PTY LTD | HWT | 09348215109622 |
| TriVerse Meniscal Insert PS+ | 121-27-8713 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215107574 |
| TriVerse Meniscal Insert CR | 02-032-47-7116 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215104221 |
| TriVerse Femoral Component CR | 121-27-7055 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215100377 |
| TriVerse Meniscal Insert PS+ | 02-032-44-5924 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215107475 |
| TriVerse Meniscal Insert PS+ | 02-032-44-6320 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH OIY | 09348215104900 |