NexGen LPS-Flex and LPS Mobile Bearing Knee System
FDA premarket approval P060037/S059 · decided 2019-07-29
Approval details
- PMA number
- P060037
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NexGen LPS-Flex and LPS Mobile Bearing Knee System
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2019-04-30
- Decision date
- 2019-07-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for updated labeling, including modified warnings and added MR Conditional language, for the NexGen LPS-Flex and LPS Mobile Bearing Knee Systems.
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510(k) clearances by this applicant
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|---|---|---|
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
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| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |