JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
FDA 510(k) clearance K222653 · decided 2022-10-28
Clearance details
- K-number
- K222653
- Device name
- JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
- Applicant
- Smith+Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-01
- Decision date
- 2022-10-28
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- NJD
- Device class
- 2
- Regulation number
- 888.3535
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (K251975) | Ignite Orthomotion | 2025-09-02 |
| ACHIEVE Partial Knee System (K242307) | Ignite Orthomotion | 2024-12-16 |
| Engage™ Partial Knee System (K190439) | Engage Uni, LLC | 2019-11-21 |
| RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811) | Mako Surgical Corp. | 2014-07-08 |
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 |