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Biomet 360 Knee System 185253

by Biomet Orthopedics, Inc.

Biomet 360 Knee System 185253 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K093293 on 22 Oct 2010 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304481886), active as of 23 Oct 2026. 5 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

None ongoing

5 closed

Documents

510(k) K093293

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304481886 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093293 Date22 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093293 decided 22 Oct 2010 Active
  • FDA GUDID UDI-DI 00880304481886 listed 24 Oct 2015 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0723-2021 FDA Class II initiated 1 Dec 2020

    Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

  • 2 recalls, same reason

    • Terminated Z-3249-2018 FDA Class II initiated 2 Aug 2018
    • Terminated Z-3250-2018 FDA Class II initiated 2 Aug 2018

    The implant only has one bolt in the sterile package but it should have had two.

    • Terminated Z-0003-2017 FDA Class II initiated 8 Aug 2016

    The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.

    • Terminated Z-2242-2014 FDA Class II initiated 1 Jul 2014

    The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Timeline

7 dated events

  1. Cleared FDA 510(k) K093293
  2. Recall initiated FDA recalls Z-2242-2014
  3. Listed FDA GUDID 00880304481886
  4. Recall initiated FDA recalls Z-0003-2017
  5. Recall initiated FDA recalls Z-3249-2018
  6. Recall initiated FDA recalls Z-3250-2018
  7. Recall initiated FDA recalls Z-0723-2021

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biomet 360 Knee System
Generic name
Knee arthroplasty wedge
Model / Ref / Catalog
185253
Primary DI / UDI-DI
00880304481886
510(k) Number
FDA product code
MBV, JWH
GMDN term
Knee arthroplasty wedge
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Knee arthroplasty wedge

Cleared under the same submission (K093293)

and 8 more cleared under K093293

Similar devices in this category

Other devices filed under Knee arthroplasty wedge.

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
Other properties (9, all answered No)