NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
FDA 510(k) clearance K031061 · decided 2003-10-09
Clearance details
- K-number
- K031061
- Device name
- NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-03
- Decision date
- 2003-10-09
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |