PMA P010014S113

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S113
Product code: NRA
Decision date: 2026-01-16
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for the introduction of an additional inspection step in the manufacturing process of the Oxford Partial Knee System to enhance the identification of components.

Current openFDA PMA Record#

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S113
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-01-16
Decision code: APPR
Date received: 2025-12-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the introduction of an additional inspection step in the manufacturing process of the Oxford Partial Knee System to enhance the identification of components.