FDA device listing
ANTHEM Total Knee System,Genesis Uni Knee System,JOURNEY BCS and II Knee Systems,JOURNEY II CR Knee System,Journey II UK…
FDA device listing 1105321410 · Smith & Nephew, Inc.
Key facts
| Proprietary names | ANTHEM Total Knee System,Genesis Uni Knee System,JOURNEY BCS and II Knee Systems,JOURNEY II CR Knee System,Journey II UK Knee System,JOURNEY II Uni Knee System,JOURNEY II XR Bi-Cruciate Retaining Knee System,JOURNEY PFJ System,JOURNEY Uni Knee System,Legion Hinge Total |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K230653 |
| Product codes | HSX, JWH, KRO, KRR, KWH, MBH, OIY |
| Device names | HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, KRO - Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, KRR - Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, KWH - Prosthesis, Toe, Constrained, Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3510, 888.3520, 888.3540, 888.3560, 888.3565, 888.3720 |
| Review panels | Orthopedic |
| Registered establishments | Smith and Nephew Operations Sdn. Bhd, Smith & Nephew, Inc., SMITH & NEPHEW, INC., SMITH & NEPHEW ORTHOPAEDICS AG |
| Establishment registrations | 1020279, 9613369, 3007366790, 3022142628 |
| FEI numbers | 1020279, 3002807893, 3007282753, 3022142628 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database