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Conformity Stem

by United Orthopedic Corporation 8 variants

Ref 9110-5020

Conformity Stem (9110-5020) is a device classified as Class IIa in the EU and Class II in the US made by United Orthopedic Corp., registered in EUDAMED on 10 Feb 2026 (Basic UDI-DI B-04711605586597), cleared under FDA 510(k) K191056 on 3 Jan 2020 (1 earlier submission) and listed in FDA GUDID since 2 Sep 2019 (UDI-DI 04711605586597), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191056

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04711605586597 Basic UDI-DI 04711605586597UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191056 Date3 Jan 2020DecidedStatusActive
United StatesGUDID listing GUDID Number04711605586597 UDI-DI Date2 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK183312 Date8 Aug 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04711605586597 registered 10 Feb 2026 Active
  • FDA 510(k) K191056 decided 3 Jan 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04711605586597 listed 2 Sep 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K183312
  2. Listed FDA GUDID 04711605586597
  3. Cleared FDA 510(k) K191056
  4. Registered EUDAMED B-04711605586597

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Femoral stem prosthesis trial
Model / Ref / Catalog
9110-5020
Primary DI / UDI-DI
04711605586597
Basic UDI-DI
B-04711605586597
510(k) Number
FDA product code
JDI, KWY, MEH, LZO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Femoral stem prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3390, 888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
France
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 IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
TW-MF-000009523
Authorised representative
mdi Europa GmbH DE-AR-000006218

Similar devices in this category

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

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)