- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S244
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-04-30
- Decision code
- APPR
- Date received
- 2020-04-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to introduce an inspection at the assembly process step to ensure the correct screw is packaged with the MBT Step Wedge components.