- Device
- NexGen LPS-Flex / LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S063
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-06-18
- Decision code
- APPR
- Date received
- 2019-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add Hot Isostatic Pressing (HIP) as an alternate process in the investment casting for NexGen Femoral components (size D, E, and F).