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Oxford® Partial Knee System 154378

by Biomet Orthopedics, Inc.

Oxford® Partial Knee System 154378 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K133940 on 28 Mar 2014 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 05019279999484), active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K133940

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05019279999484 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133940 Date28 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133940 decided 28 Mar 2014 Active
  • FDA GUDID UDI-DI 05019279999484 listed 24 Oct 2015 Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-1018-2023 FDA Class II initiated 15 Dec 2022

    Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier

    • Terminated Z-0624-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-2148-2020 FDA Class II initiated 17 Apr 2020

    Potential presence of elevated endotoxin levels that exceed the specification limit

    • Terminated Z-0956-2017 FDA Class II initiated 6 Dec 2016

    Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.

Timeline

6 dated events

  1. Cleared FDA 510(k) K133940
  2. Listed FDA GUDID 05019279999484
  3. Recall initiated FDA recalls Z-0956-2017
  4. Recall initiated FDA recalls Z-2148-2020
  5. Recall initiated FDA recalls Z-0624-2021
  6. Recall initiated FDA recalls Z-1018-2023

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Oxford® Partial Knee System
Generic name
Unicondylar knee prosthesis
Model / Ref / Catalog
154378
Primary DI / UDI-DI
05019279999484
510(k) Number
FDA product code
HRY
GMDN term
Unicondylar knee prosthesis
Device class
Class II
Regulation number
888.3530
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Unicondylar knee prosthesis

Cleared under the same submission (K133940)

and 8 more cleared under K133940

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)