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Biomet® Knee System 148252

by Biomet Orthopedics, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171054 Date28 Jul 2017DecidedStatusActive
United StatesGUDID listing Number00880304505667 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

10 recalls · FDA

    • Terminated Z-0938-2019 FDA Class II initiated 21 Dec 2018

    Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

    • Terminated Z-2289-2018 FDA Class II initiated 24 May 2018

    Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

    • Terminated Z-2177-2018 FDA Class II initiated 18 May 2018

    One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

    • Terminated Z-2183-2018 FDA Class II initiated 11 May 2018

    The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

    • Terminated Z-1219-2017 FDA Class II initiated 15 Dec 2016

    Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps 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-1756-2015 FDA Class III initiated 16 Apr 2015

    Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

    • Terminated Z-2104-2011 FDA Unclassified (pre-2012) initiated 3 Mar 2011

    The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".

  • 2 recalls, same reason

    • Terminated Z-0706-2008 FDA Unclassified (pre-2012) initiated 12 Dec 2007
    • Terminated Z-0707-2008 FDA Unclassified (pre-2012) initiated 12 Dec 2007

    Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

    • Terminated Z-0255-2008 FDA Unclassified (pre-2012) initiated 18 Sep 2007

    Mislabeled as to size: the package actaully contained a 71 mm tray.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biomet® Knee System
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
148252
Primary DI / UDI-DI
00880304505667
510(k) Number
FDA product code
JWH, MBV, MBH, HRY, OIY
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3560, 888.3565, 888.3530
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Knee femur stem prosthesis

Cleared under the same submission (K142933)

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Cleared under the same submission (K171054)

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Cleared under the same submission (K915132)

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Other devices from Biomet Orthopedics, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No