JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
FDA 510(k) clearance K242711 · decided 2024-10-30
Clearance details
- K-number
- K242711
- Device name
- JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-09
- Decision date
- 2024-10-30
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| Cambridge Partial Knee (K251771) | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| Persona Partial Knee (K251834) | Zimmer Biomet | 2025-08-15 |
| MOTO Partial Knee System Extension (K251618) | Medacta International S.A. | 2025-07-24 |
| Arthrex iBalance Partial Knee System (K251453) | Arthrex, Inc. | 2025-07-01 |
| ACTIFY™ Unicondylar Knee System (K241260) | Globus Medical, Inc. | 2024-12-06 |
| OvertureTi Knee Resurfacing SystemTM (K242746) | Overture Orthopaedics | 2024-10-07 |
| TRIBRID® Unicompartmental Knee System (K232114) | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| Uni Knee Resurfacing System (K221292) | Overture Resurfacing, Inc. | 2023-03-10 |
| TLC Unicompartmental Knee System (K212870) | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| Restoris Multi-Compartmental Knee System (K220930) | Mako Surgical Corp. | 2022-06-02 |
| Balanced Knee System Uni (K211471) | Ortho Development Corporation | 2021-12-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |