PMA P010014S114

Device: Oxford Cementless Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S114
Product code: NRA
Decision date: 2026-03-06
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: removal of in-process cleaning step of the Oxford Cementless Partial Knee components at DOT GmbH, Germany facility

Current openFDA PMA Record#

Device: Oxford Cementless Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S114
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-03-06
Decision code: OK30
Date received: 2026-02-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of in-process cleaning step of the Oxford Cementless Partial Knee components at DOT GmbH, Germany facility