Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K223062
World Total Knee System · Signature Orthopaedics Pty, Ltd. · decided 2022-11-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| World Knee PS TiN Femur Left | 121-20-4901 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215106065 |
| World Knee PS TiN Femur Symmetric | 121-20-4303 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105723 |
| World Knee CR TiN Femur Right | 121-20-4912 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215106102 |
| World Knee CR TiN Femur Left | 121-20-4811 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215106034 |
| World Knee CR TiN Femur Symmetric | 121-20-4513 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105877 |
| World Knee PS TiN Femur Symmetric | 121-20-4203 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105662 |
| World Knee PS TiN Femur Symmetric | 121-20-4403 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105785 |
| World Knee PS TiN Femur Right | 121-20-4302 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105716 |
| World Knee CR TiN Femur Left | 121-20-4111 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105617 |
| World Knee PS TiN Femur Left | 121-20-4101 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105587 |
| World Knee PS TiN Femur Left | 121-20-4401 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105761 |
| World Knee PS TiN Femur Symmetric | 121-20-4903 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215106089 |
| World Knee CR TiN Femur Left | 121-20-4511 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105853 |
| World Knee PS TiN Femur Right | 121-20-4602 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105891 |
| World Knee CR TiN Femur Left | 121-20-4411 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105792 |
| World Knee CR TiN Femur Symmetric | 121-20-4113 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105631 |
| World Knee CR TiN Femur Symmetric | 121-20-4913 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215106119 |
| World Knee CR TiN Femur Right | 121-20-4412 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105808 |
| World Knee CR TiN Femur Right | 121-20-4712 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105983 |
| World Knee CR TiN Femur Right | 121-20-4612 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105921 |
| World Knee CR TiN Femur Right | 121-20-4312 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105747 |
| World Knee CR TiN Femur Right | 121-20-4512 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105860 |
| World Knee PS TiN Femur Left | 121-20-4601 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105884 |
| World Knee CR TiN Femur Left | 121-20-4211 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105679 |
| World Knee CR TiN Femur Symmetric | 121-20-4713 | SIGNATURE ORTHOPAEDICS PTY LTD | JWH | 09348215105990 |