NexGen® LPS-Flex / LPS-Mobile Bearing Knee
FDA premarket approval P060037/S080 · decided 2022-08-15
Approval details
- PMA number
- P060037
- Supplement
- S080
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2022-07-25
- Decision date
- 2022-08-15
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for revising device labeling, specifically package inserts, to implement the following changes: removal of re-sterilization information; addition of caution information for metal sensitivity and product cleanliness; addition of contact information for product compatibility questions; disclosure of residual risks with products; and addition of product disposal information.
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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 |