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Anatomic Shoulder Prosthesis 04.01.0091

by Medacta International

Ref 04.01.0091

Anatomic Shoulder Prosthesis 04.01.0091 is a device classified as Class III in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-07630040713146), cleared under FDA 510(k) K170910 on 16 Aug 2017 and listed in FDA GUDID since 24 Aug 2017 (UDI-DI 07630040713146), 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 MDD 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) K170910

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/MDD EUDAMED NumberB-07630040713146 Basic UDI-DI 07630040713146UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040713146 UDI-DI Date24 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170910 Date16 Aug 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040713146 registered 26 Oct 2026 Active
  • FDA 510(k) K170910 decided 16 Aug 2017 Active
  • FDA GUDID UDI-DI 07630040713146 listed 24 Aug 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-0775-2020 FDA Class II initiated 4 Nov 2019

    Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

Timeline

4 dated events

  1. Cleared FDA 510(k) K170910
  2. Listed FDA GUDID 07630040713146
  3. Recall initiated FDA recalls Z-0775-2020
  4. Registered EUDAMED B-07630040713146

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Metal humeral head Ø42 EUDAMED
Anatomic Shoulder Prosthesis GUDID
Generic name
Total shoulder prosthesis
Device name
Shoulder Humeral head (metal)
Model / reference
04.01.0091
Primary DI / UDI-DI
07630040713146
Basic UDI-DI
B-07630040713146
510(k) Number
FDA product code
KWS
EMDN code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN term
Total shoulder prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Total shoulder prosthesis

Cleared under the same submission (K170910)

and 8 more cleared under K170910

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS.

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)