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Balance Hip System 180001

by Biomet Orthopedics, Inc.

Balance Hip System 180001 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K050251 on 27 May 2005 (2 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304268517), active as of 23 Oct 2026. 3 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304268517 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050251 Date27 May 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050251 decided 27 May 2005 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00880304268517 listed 24 Oct 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0523-2020 FDA Class II initiated 21 Aug 2019

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    • Terminated Z-1754-2015 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-1122-2015 FDA Class II initiated 9 Jan 2015

    Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Timeline

7 dated events

  1. Cleared FDA 510(k) K921224
  2. Cleared FDA 510(k) K030055
  3. Cleared FDA 510(k) K050251
  4. Recall initiated FDA recalls Z-1122-2015
  5. Recall initiated FDA recalls Z-1754-2015
  6. Listed FDA GUDID 00880304268517
  7. Recall initiated FDA recalls Z-0523-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Balance Hip System
Generic name
Coated hip femur prosthesis, modular
Model / Ref / Catalog
180001
Primary DI / UDI-DI
00880304268517
510(k) Number
FDA product code
LZO, LZY, MEH, KWY, JDI, LPH, KWZ
GMDN term
Coated hip femur prosthesis, modular
Device class
Class II
Regulation number
888.3353, 888.3360, 888.3390, 888.3350, 888.3358, 888.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated hip femur prosthesis, modular

Cleared under the same submission (K030055)

and 8 more cleared under K030055

Cleared under the same submission (K050251)

and 8 more cleared under K050251

Similar devices

Other devices filed under FDA product code LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented).

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)