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Humeris 135 322-0806

by Fx Solutions

Ref 322-0806

Humeris 135 322-0806 is a device classified as Class III in the EU and Class II in the US made by Fx Solutions, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-03701037310410), cleared under FDA 510(k) K222936 on 7 Nov 2022 and listed in FDA GUDID since 11 Jan 2023 (UDI-DI 03701037310410), active as of 22 Oct 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222936

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701037310410 Basic UDI-DI 03701037310410UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037310410 UDI-DI Date11 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222936 Date7 Nov 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03701037310410 registered 16 Jun 2026 Active
  • FDA 510(k) K222936 decided 7 Nov 2022 Active
  • FDA GUDID UDI-DI 03701037310410 listed 11 Jan 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222936
  2. Listed FDA GUDID 03701037310410
  3. Registered EUDAMED B-03701037310410

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  • Withdrawn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
Humeris 135
Generic name
Polyethylene reverse shoulder prosthesis cup
Model / Ref / Catalog
322-0806
Primary DI / UDI-DI
03701037310410
Basic UDI-DI
B-03701037310410
510(k) Number
FDA product code
PHX, KWT, HSD
EMDN code
P090104010202 Epiphysary humeral components for reverse prostheses - humeral cups
GMDN term
Polyethylene reverse shoulder prosthesis cup
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3650, 888.3690
EU registration type
Legacy device (under a directive)
EU market of registration
France
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: Polyethylene reverse shoulder prosthesis cup

Cleared under the same submission (K222936)

and 8 more cleared under K222936

Similar devices in this category

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

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)