PMA P010014S102

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S102
Product code: NRA
Decision date: 2022-07-14
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for updating the currently approved U.S. labeling for the Oxford® Partial Knee System, including instructions for use (IFU), packaging labeling, inclusion of a new Information for Patient/IFP document, and Patient Implant Card.

Current openFDA PMA Record#

Device: Oxford Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S102
Product code: NRA
Generic name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-07-14
Decision code: APPR
Date received: 2022-06-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updating the currently approved U.S. labeling for the Oxford® Partial Knee System, including instructions for use (IFU), packaging labeling, inclusion of a new Information for Patient/IFP document, and Patient Implant Card.