PMA P010014

Device: Oxford™ Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S103
Product code: NRA
Decision date: 2026-07-13
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: change to the creep test pressure parameter in the package performance testing of the Oxford Partial Knee System Bearing Components

Current openFDA PMA Record#

Device: Oxford™ Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S117
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-07-13
Decision code: OK30
Date received: 2026-06-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change to the creep test pressure parameter in the package performance testing of the Oxford Partial Knee System Bearing Components