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Comprehensive 405803

by Biomet Orthopedics, Inc.

Comprehensive 405803 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K120121 on 16 Feb 2012 and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00880304532342), active as of 23 Oct 2026. 2 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

4 closed

Documents

510(k) K120121

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 Number00880304532342 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK120121 Date16 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120121 decided 16 Feb 2012 Active
  • FDA GUDID UDI-DI 00880304532342 listed 27 Oct 2016 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0093-2021 FDA Class II initiated 2 Sep 2020 on shared 510(k) K120121

    Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

    • Terminated Z-1615-2020 FDA Class II initiated 25 Feb 2020 on shared 510(k) K120121

    Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

    • Terminated Z-0972-2019 FDA Class II initiated 21 Dec 2018

    The product was potentially being packaged without a taper adapter.

    • Terminated Z-1208-2015 FDA Class II initiated 7 Jan 2015

    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K120121
  2. Recall initiated FDA recalls Z-1208-2015
  3. Listed FDA GUDID 00880304532342
  4. Recall initiated FDA recalls Z-0972-2019
  5. Recall initiated FDA recalls Z-1615-2020
  6. Recall initiated FDA recalls Z-0093-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive
Generic name
Orthopaedic implant aiming/guiding block, reusable
Model / Ref / Catalog
405803
Primary DI / UDI-DI
00880304532342
510(k) Number
FDA product code
KWS
GMDN term
Orthopaedic implant aiming/guiding block, reusable
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant aiming/guiding block, reusable

Cleared under the same submission (K120121)

and 8 more cleared under K120121

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)