DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
FDA 510(k) clearance K061648 · decided 2006-09-11
Clearance details
- K-number
- K061648
- Device name
- DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-13
- Decision date
- 2006-09-11
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NPJ
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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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 |
| SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056) | Smith & Nephew, Inc. | 2009-12-15 |
| 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 |
| 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
| Record | Firm | Date |
|---|---|---|
| (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 106032 recall (Z-1219-2018) | DePuy Orthopaedics, Inc. | 2018-03-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |