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Shoulder System 04.01.0127

by Medacta International SA

Ref 04.01.0127

Shoulder System 04.01.0127 is a device classified as Class III in the EU and Class II in the US made by Medacta International SA, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-07630040706346), cleared under FDA 510(k) K170452 on 5 Oct 2017 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 07630040706346), active as of 12 Nov 2026.

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 found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170452

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630040706346 Basic UDI-DI 07630040706346UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040706346 UDI-DI Date15 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170452 Date5 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040706346 registered 26 Oct 2026 Active
  • FDA 510(k) K170452 decided 5 Oct 2017 Active
  • FDA GUDID UDI-DI 07630040706346 listed 15 Nov 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170452
  2. Listed FDA GUDID 07630040706346
  3. Registered EUDAMED B-07630040706346

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  • Withdrawn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
Humeral reverse HC liner Ø42/+6mm EUDAMED
Shoulder System GUDID
Generic name
Total shoulder prosthesis
Device name
Shoulder Humeral reverse liner - HCPE
Model / reference
04.01.0127
Primary DI / UDI-DI
07630040706346
Basic UDI-DI
B-07630040706346
510(k) Number
FDA product code
PHX
EMDN code
P090104010201 Epiphysary humeral components for reverse prostheses - inserts
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 (K170452)

and 8 more cleared under K170452

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR REVERSE PROSTHESES - INSERTS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

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