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Comprehensive® Reverse Shoulder 110040130

by Biomet Orthopedics, Inc.

Ref 110040130

Comprehensive® Reverse Shoulder 110040130 is a device classified as Class I in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI 889024-ZB002620-FQ), cleared under FDA 510(k) K172502 on 3 Jan 2018 and listed in FDA GUDID since 14 Sep 2018 (UDI-DI 00887868254420), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172502

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB002620-FQ Basic UDI-DI 00887868254420UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868254420 UDI-DI Date14 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172502 Date3 Jan 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002620-FQ registered 1 Nov 2026 Active
  • FDA 510(k) K172502 decided 3 Jan 2018 Active
  • FDA GUDID UDI-DI 00887868254420 listed 14 Sep 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

4 dated events

  1. Cleared FDA 510(k) K172502
  2. Listed FDA GUDID 00887868254420
  3. Recall initiated FDA recalls Z-0520-2020
  4. Registered EUDAMED 889024-ZB002620-FQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Comprehensive® Reverse Shoulder
Generic name
Surgical implant template, reusable
Device name
Augmented Baseplate Augment Sizer
Model / Ref / Catalog
110040130
Primary DI / UDI-DI
00887868254420
Basic UDI-DI
889024-ZB002620-FQ
Direct marketing DI
00887868254420
510(k) Number
FDA product code
KWS, PHX, MBF, KWT, PAO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical implant template, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3670, 888.3650
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K172502)

and 8 more cleared under K172502

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)