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Humeris Shoulder 316-0012

by Fx Solutions

Ref 316-0012

Humeris Shoulder 316-0012 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-03701037301579), cleared under FDA 510(k) K163669 on 17 May 2017 and listed in FDA GUDID since 22 May 2017 (UDI-DI 03701037301579), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163669

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701037301579 Basic UDI-DI 03701037301579UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701037301579 UDI-DI Date22 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163669 Date17 May 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03701037301579 registered 16 Jun 2026 Active
  • FDA 510(k) K163669 decided 17 May 2017 Active
  • FDA GUDID UDI-DI 03701037301579 listed 22 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163669
  2. Listed FDA GUDID 03701037301579
  3. Registered EUDAMED B-03701037301579

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  • Withdrawn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 Shoulder
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
316-0012
Primary DI / UDI-DI
03701037301579
Basic UDI-DI
B-03701037301579
510(k) Number
FDA product code
PHX, HSD
EMDN code
P0901040201 Shoulder prostheses non modular stems
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3660, 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: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K163669)

and 8 more cleared under K163669

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES NON MODULAR STEMS.

Other devices from Fx Solutions

See all devices from Fx Solutions →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (18, all answered No)