PMA P830055S378
- Device
- LCS® Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S378
- Product code
- NJL
- Decision date
- 2026-10-27
- Classification
- Orthopedic
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- introduction of an in-house X-ray inspection process at DePuy Synthes manufacturing facility in Raynham, Massachusetts
Current openFDA PMA Record#
- Device
- LCS® Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S378
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-10-27
- Decision code
- OK30
- Date received
- 2026-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of an in-house X-ray inspection process at DePuy Synthes manufacturing facility in Raynham, Massachusetts