NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
FDA 510(k) clearance K060370 · decided 2006-04-28
Clearance details
- K-number
- K060370
- Device name
- NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-13
- Decision date
- 2006-04-28
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- JWH
- 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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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Nexgen LPS Femoral and Tibial Knee components (P060037/S098) | Zimmer, Inc. | 2026-07-20 |
| Creep Pressure Test Update for the Nexgen LPS Bearing Knee (P060037/S097) | Zimmer, Inc. | 2026-07-20 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S096) | Zimmer, Inc. | 2026-01-16 |
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |