PMA P010014S107

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S107
Product code: NRA
Decision date: 2024-11-22
Classification: Orthopedic
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for implementing Steris Libertyville South site (FEI # 3003015552; Registration # 1424263) as the main Gamma sterilization site for the Oxford Partial Knee tibial trays, twin peg femoral components and meniscal bearings, manufactured at Biomet Inc.

Current openFDA PMA Record#

Device: Oxford® Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S107
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2024-11-22
Decision code: APPR
Date received: 2024-07-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for implementing Steris Libertyville South site (FEI # 3003015552; Registration # 1424263) as the main Gamma sterilization site for the Oxford Partial Knee tibial trays, twin peg femoral components and meniscal bearings, manufactured at Biomet Inc.