PMA P010014S105

Device: Oxford™ Cementless Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S105
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: The Oxford Cementless Partial Knee System is indicated for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of bone cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant.

Current openFDA PMA Record#

Device: Oxford™ Cementless Partial Knee System
Applicant: Biomet Manufacturing Corp
PMA number: P010014
Supplement: S105
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: 2023-06-05
Supplement type: Panel Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The Oxford Cementless Partial Knee System is indicated for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of bone cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant.