- Device
- Oxford™ Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S111
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2025-08-07
- Decision code
- OK30
- Date received
- 2025-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduction of Nitric biological upgrade cycle time within the nitric immersion tanks and the heated immersion rinse tanks from 600 seconds to 300 seconds, and use of an additional Biological Upgrade Line for Nitric Biological Upgrade process at the Zimmer Orthopedics Manufacturing Limited, Shannon, Ireland facility