PMA P010014S119

Device: Cementless Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S119
Product code: NRA
Decision date: 2026-10-06
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: introduction of an additional Solvent Wash Step to the final cleaning of the femoral and tibial components of the Oxford™ Cementless Partial Knee System at the Shannon, Ireland facility

Current openFDA PMA Record#

Device: Cementless Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S119
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-10-06
Decision code: OK30
Date received: 2026-08-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of an additional Solvent Wash Step to the final cleaning of the femoral and tibial components of the Oxford™ Cementless Partial Knee System at the Shannon, Ireland facility