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Oxford Partial Knee System

by Biomet Manufacturing Corp

PMA P010014

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

22 closed

Documents

PMA P010014↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP010014 Date21 Apr 2004ApprovedStatusActive

Recalls

22 recalls · FDA

  • 20 recalls, same reason

    • Terminated Z-1153-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1168-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1162-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1152-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1159-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1170-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1165-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1173-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1158-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1172-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1161-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1169-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1157-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1163-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1155-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1156-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1154-2017 FDA Class II initiated 5 Jan 2016 on shared PMA P010014
    • Terminated Z-1164-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1160-2017 FDA Class II initiated 5 Jan 2016
    • Terminated Z-1171-2017 FDA Class II initiated 5 Jan 2016

    Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

    • Terminated Z-2698-2011 FDA Unclassified (pre-2012) initiated 22 Apr 2011 on shared PMA P010014

    This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

    • Terminated Z-0962-2009 FDA Unclassified (pre-2012) initiated 19 Dec 2008

    Packages labeled as "right" actually contain a "left" component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Oxford(Tm) Meniscal Unicompartmental Knee System
Generic Name
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
PMA Number
FDA Product Code
NRA
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Oxford Partial Knee System is a unicompartmental knee prosthesis designed for femorotibial joint replacement. It is a semi-constrained, metal/polymer mobile bearing implant indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the knee.

The device is intended to be implanted with bone cement and is classified as a Class III medical device under FDA PMA authorization. It is supplied as a sterile, single-use implant for surgical use in orthopedic settings.

Other devices from Biomet Manufacturing Corp

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Oxford Partial Knee System indicated for?

    The Oxford Partial Knee System is indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the knee, as stated in the approval documentation for the device.

  • Is the Oxford Partial Knee System implanted with bone cement?

    Yes, the device is intended to be implanted with bone cement, as specified in the approval statement provided in the device data.

  • What type of prosthesis is the Oxford Partial Knee System classified as?

    The Oxford Partial Knee System is classified as a femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing prosthesis, according to the generic name and openfda fields in the device specifications.