STRYKER COMPARTMENTAL KNEE SYSTEM
FDA 510(k) clearance K052917 · decided 2005-12-27
Clearance details
- K-number
- K052917
- Device name
- STRYKER COMPARTMENTAL KNEE SYSTEM
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-17
- Decision date
- 2005-12-27
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- NPJ
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, 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 |
| 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 |
| SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896) | Smith & Nephew, Inc. | 2005-01-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 recall (Z-0893-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308 recall (Z-0894-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508 recall (Z-0895-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708 recall (Z-0896-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 recall (Z-0897-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910 recall (Z-0900-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica Internationa recall (Z-0606-2012) | Stryker Howmedica Osteonics Corp. | 2012-01-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |