NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
FDA 510(k) clearance K991581 · decided 1999-07-30
Clearance details
- K-number
- K991581
- Device name
- NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-07
- Decision date
- 1999-07-30
- Days to decision
- 84 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
| Record | Firm | Date |
|---|---|---|
| Product 54 consists of all product under product code: JWH and same usage: Item no: 596009 recall (Z-1152-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofe recall (Z-0832-2016) | Zimmer Biomet, Inc. | 2016-02-22 |
| MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP recall (Z-1023-2014) | Zimmer, Inc. | 2014-02-20 |
| NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zi recall (Z-0609-2011) | Zimmer Inc. | 2010-12-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |