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Comprehensive® Reverse Shoulder 110029092

by Biomet Orthopedics, Inc.

Comprehensive® Reverse Shoulder 110029092 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K172502 on 3 Jan 2018 and listed in FDA GUDID since 2 Mar 2018 (UDI-DI 00880304811249), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K172502

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 Number00880304811249 UDI-DI Date2 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172502 Date3 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172502 decided 3 Jan 2018 Active
  • FDA GUDID UDI-DI 00880304811249 listed 2 Mar 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-0520-2020 FDA Class II initiated 21 Aug 2019

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K172502
  2. Listed FDA GUDID 00880304811249
  3. Recall initiated FDA recalls Z-0520-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive® Reverse Shoulder
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
110029092
Primary DI / UDI-DI
00880304811249
510(k) Number
FDA product code
PHX, KWT, PAO, MBF, KWS
GMDN term
Surgical drill guide, reusable
Device class
Class II
Regulation number
888.3660, 888.3650, 888.3670
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K172502)

and 8 more cleared under K172502

Similar devices in this category

Other devices filed under Surgical drill guide, reusable.

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, all answered No)