- Device
- Oxford® Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S116
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2026-05-12
- Decision code
- OK30
- Date received
- 2026-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change to the surface quality inspection process of tibial tray and femoral components of the Oxford Cementless Partial Knee system at DOT GmbH, Germany