PMA P830055S237
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S237
- Product code
- NJL
- Decision date
- 2019-11-14
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of an alternate casting site for the ATTUNE Revision Femoral Component material casting process. This change will add the DePuy Synthes Raynham, MA facility in addition to Orchid Orthopedic Solutions, the current external supplier.
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S237
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-11-14
- Decision code
- OK30
- Date received
- 2019-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate casting site for the ATTUNE Revision Femoral Component material casting process. This change will add the DePuy Synthes Raynham, MA facility in addition to Orchid Orthopedic Solutions, the current external supplier.