Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K230653
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates · Smith & Nephew, Inc. · decided 2023-05-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| JOURNEY | 71422354 | Smith & Nephew, Inc. | HSX | 03596010627407 |
| JOURNEY | 71422347 | Smith & Nephew, Inc. | HSX | 03596010627360 |
| LEGION | 71424106 | Smith & Nephew, Inc. | JWH | 03596010617965 |
| JOURNEY | 74023263 | Smith & Nephew, Inc. | JWH | 03596010555229 |
| JOURNEY | 74022223 | Smith & Nephew, Inc. | JWH | 03596010554314 |
| GENESIS | 725006 | Smith & Nephew, Inc. | HSX | 03596010256829 |
| ENGAGE | 1-10013-309 | Smith & Nephew, Inc. | HSX NJD | 00885556873397 |
| JOURNEY | 74026280 | Smith & Nephew, Inc. | HSX | 00885556680919 |
| JOURNEY | 74026262 | Smith & Nephew, Inc. | HSX | 00885556680667 |
| Anthem | 71422973 | Smith & Nephew, Inc. | JWH | 00885556656075 |
| JOURNEY II | 71935212 | Smith & Nephew, Inc. | HSX | 00885556578919 |
| Legion | 71426144 | Smith & Nephew, Inc. | JWH MBH | 00885556538425 |
| JOURNEY | 74025622 | Smith & Nephew, Inc. | JWH | 00885556422663 |
| JOURNEY | 74025635 | Smith & Nephew, Inc. | JWH | 00885556422564 |
| JOURNEY | 74029263 | Smith & Nephew, Inc. | JWH | 00885556176511 |
| LEGION | 71934171 | Smith & Nephew, Inc. | JWH | 00885556143216 |
| LEGION | 71423203 | Smith & Nephew, Inc. | JWH | 00885556030608 |
| LEGION | 71421208 | Smith & Nephew, Inc. | JWH | 00885556029701 |
| JOURNEY | 71422295 | Smith & Nephew, Inc. | HSX | 03596010589279 |
| JOURNEY | 74024832 | Smith & Nephew, Inc. | JWH | 03596010554536 |
| LEGION | 71421713 | Smith & Nephew, Inc. | JWH | 03596010544971 |
| Legion | 71935409 | Smith & Nephew, Inc. | JWH MBH | 00885556645611 |
| JOURNEY II XR | 74023986 | Smith & Nephew, Inc. | JWH | 00885556616208 |
| LEGION | 71453284 | Smith & Nephew, Inc. | JWH | 00885556255643 |
| JOURNEY | 71934511 | Smith & Nephew, Inc. | JWH | 00885556181416 |