NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
FDA premarket approval P060037/S069 · decided 2020-12-21
Approval details
- PMA number
- P060037
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2020-09-28
- Decision date
- 2020-12-21
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Change to the design and materials of the device packaging system for the ultra-high molecular weight polyethylene (UHMWPE) tibial articular surface components of the NexGen LPS-Flex Mobile / LPS-Mobile Bearing Knee System and an associated change to the product shelf life.
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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 |