PMA P010014S115

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S115
Product code: NRA
Decision date: 2026-04-20
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for a change to the laser etching process of tibial tray and femoral components of the Oxford Partial Knee System

Current openFDA PMA Record#

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S115
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-04-20
Decision code: OK30
Date received: 2026-03-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a change to the laser etching process of tibial tray and femoral components of the Oxford Partial Knee System