NexGen® LPS-Flex LPS-Mobile Bearing Knee
FDA premarket approval P060037/S091 · decided 2024-07-05
Approval details
- PMA number
- P060037
- Supplement
- S091
- Supplement type
- 30-Day Notice
- 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
- 2024-06-27
- Decision date
- 2024-07-05
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- two changes to the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components manufactured at the Zimmer Orthopedics Manufacturing Limited, Shannon, Ireland facility. Change One includes changing the order of the manufacturing process flow steps, to introduce additional in-process cleaning step, and to introduce anewer model of the laser etch equipment and fixture for the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components. Change Two includes the introduction of Haas Mult
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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 |