NexGen® LPS-Flex / LPS-Mobile Bearing Knee
FDA premarket approval P060037/S086 · decided 2023-12-22
Approval details
- PMA number
- P060037
- Supplement
- S086
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NexGen® LPS-Flex / LPS-Mobile Bearing Knee
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2023-12-05
- Decision date
- 2023-12-22
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for adding Temperature of the nitric acid and final rinse tank conductivity to be monitored for NexGen® LPS-Flex / LPS-Mobile Bearing Knee and tightening nitric acid upgrade time in a nitric acid bioburden reduction process for UHMWPE components of NexGen® LPS-Flex / LPS-Mobile Bearing Knee.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
| Augment Off-Axis Instrument System (K261683) | Zimmer, Inc. | 2026-06-16 |
| Zimmer® Persona® Personalized Knee System (K251840) | Zimmer, Inc. | 2026-05-28 |
| Avenir® Müller Stem; Avenir Complete™ Hip System (K260182) | Zimmer, Inc. | 2026-04-27 |
| Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592) | Zimmer, Inc. | 2026-04-13 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189) | Zimmer, Inc. | 2026-03-09 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |