Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K240683
Rx Knee System · Signature Orthopaedics Pty, Ltd. · decided 2024-09-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Rx Knee AP Symmetrical Augment Size 7 - 8mm Titanium Half | 121-20-9467 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215147020 |
| Rx Knee Femoral Augment | 121-25-0124 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215123116 |
| Rx Knee AP Symmetrical Augment Size 9 - 4mm Titanium Half | 121-20-9279 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215111625 |
| Rx Knee AP Symmetrical Augment Size 4 - 4mm Poly | 121-20-9164 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215110277 |
| Rx Knee AP Symmetrical Augment Size 1 - 4mm Titanium | 121-20-9241 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215111274 |
| Rx Knee AP Symmetrical Augment Size 3 - 8mm Poly Half Draft Right | 121-20-9203 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215110628 |
| Rx Knee AP Symmetrical Augment Size 6 - 8mm Poly Half Draft Left | 121-20-9356 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215146740 |
| Rx Knee AP Symmetrical Augment Size 8 - Poly Wedged 3 DEG Left | 121-20-9228 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215124151 |
| Rx Knee AP Symmetrical Augment Size 2 - 4mm Titanium Half | 121-20-9272 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215111557 |
| Rx Knee AP Symmetrical Augment Size 7 - 4mm Titanium Third | 121-20-9337 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215123871 |
| Rx Knee AP Symmetrical Augment Size 6 - 4mm Titanium | 121-20-9246 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215111328 |
| Rx Knee AP Symmetrical Augment Size 8 - 8mm Poly Half Draft Right | 121-20-9208 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215110673 |
| Rx Knee AP Symmetrical Augment Size 9 - 12mm Titanium Half Draft Left | 121-20-9499 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215147310 |
| Rx Knee AP Symmetrical Augment Size 9 - 8mm Poly Half Draft Right | 121-20-9209 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215110680 |
| Rx Knee AP Symmetrical Augment Size 7 - Poly Wedged 3 DEG Left | 121-20-9227 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215124144 |
| Rx Knee AP Symmetrical Augment Size 9 - 8mm Titanium Half Draft Right | 121-20-9289 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215111717 |
| Rx Knee AP Symmetrical Augment Size 4 - 8mm Poly Half Draft Left | 121-20-9354 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215146726 |
| Rx Knee CR Cemented Symmetrical Femur | 121-25-0315 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215122997 |
| Rx Knee AP Symmetrical Augment Size 1 - 12mm Titanium Half | 121-20-9481 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215147143 |
| Rx Knee Universal Tibial Stem Adapter Screw | 121-20-9153 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215112363 |
| Rx Knee Femoral Augment | 121-25-0114 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215123109 |
| Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly Draft | 121-20-9187 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215110482 |
| Rx Knee AP Symmetrical Augment Size 6 - 12mm Poly Half Draft Left | 121-20-9376 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215146924 |
| Rx Knee Universal Stem End Cap | 121-25-0217 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215123680 |
| Rx Knee AP Symmetrical Augment Size 7 - 12mm Poly Half | 121-20-9367 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215146849 |