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Quadrant Sparing Hip System 11-105144

by Biomet Orthopedics, Inc.

Quadrant Sparing Hip System 11-105144 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K050124 on 4 Oct 2005 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304200746), active as of 23 Oct 2026.

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

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304200746 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050124 Date4 Oct 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050124 decided 4 Oct 2005 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304200746 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0415-2013 FDA Class II initiated 4 Oct 2012 on shared 510(k) K050124

    The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K920640
  2. Cleared FDA 510(k) K050124
  3. Recall initiated FDA recalls Z-0415-2013
  4. Listed FDA GUDID 00880304200746

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Quadrant Sparing Hip System
Generic name
Acetabular shell
Model / Ref / Catalog
11-105144
Primary DI / UDI-DI
00880304200746
510(k) Number
FDA product code
MAY, MEH, KWZ, LPH, JDI
GMDN term
Acetabular shell
Device class
Class II
Regulation number
888.3353, 888.3310, 888.3358, 888.3350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Acetabular shell

Cleared under the same submission (K050124)

and 8 more cleared under K050124

Cleared under the same submission (K920640)

and 8 more cleared under K920640

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)