SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
FDA 510(k) clearance K093056 · decided 2009-12-15
Clearance details
- K-number
- K093056
- Device name
- SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-30
- Decision date
- 2009-12-15
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- NPJ
- Device class
- 2
- Regulation number
- 888.3560
- 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 |
|---|---|---|
| RESTORIS Multicompartmental Knee System (K150307) | Mako Surgical Corp. | 2015-03-10 |
| RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (K133039) | Mako Surgical Corporation | 2013-12-10 |
| IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513) | Conformis, Inc. | 2009-12-16 |
| RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (K090763) | Mako Surgical Corporation | 2009-06-17 |
| DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849) | DePuy Orthopaedics, Inc. | 2007-06-26 |
| DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648) | DePuy Orthopaedics, Inc. | 2006-09-11 |
| SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569) | Smith & Nephew, Inc. | 2006-07-06 |
| CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488) | Conformis, Inc. | 2006-03-09 |
| SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265) | Smith & Nephew, Inc. | 2005-12-27 |
| STRYKER COMPARTMENTAL KNEE SYSTEM (K052917) | Howmedica Osteonics Corp. | 2005-12-27 |
| SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896) | Smith & Nephew, Inc. | 2005-01-12 |
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 |