Skip to content

Vanguard XP® Instrumentation 32-700307

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

12 closed

Documents

510(k) K122160

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868500671 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122160 Date20 Mar 2013DecidedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-2530-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2503-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2515-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2537-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2533-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2528-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2532-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2535-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2536-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2531-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2529-2019 FDA Class II initiated 15 Aug 2019
    • Terminated Z-2534-2019 FDA Class II initiated 15 Aug 2019

    The locking bar not fully engaging

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vanguard XP® Instrumentation
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
32-700307
Primary DI / UDI-DI
00887868500671
510(k) Number
FDA product code
JWH, MBH, OIY, MBV
GMDN term
Surgical implant template, reusable
Device class
Class II
Regulation number
888.3560, 888.3565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K122160)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No