PMA P010014S109

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S109
Product code: NRA
Decision date: 2025-08-07
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for new Cemented and Cementless versions of the Oxford Partial Knee System Tibial Tray component (referred to as the Oxford Anatomic Tibial components).

Current openFDA PMA Record#

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S109
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-08-07
Decision code: APPR
Date received: 2025-05-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for new Cemented and Cementless versions of the Oxford Partial Knee System Tibial Tray component (referred to as the Oxford Anatomic Tibial components).