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U2 Total Knee System

by United Orthopedic Corporation 704 variants

Ref 2303-1216

U2 Total Knee System (2303-1216) is a device classified as Class III in the EU and Class II in the US made by United Orthopedic Corp., registered in EUDAMED on 30 Dec 2024 (Basic UDI-DI B-04711605574747), cleared under FDA 510(k) K150829 on 25 Sep 2015 and listed in FDA GUDID since 4 Dec 2015 (UDI-DI 04711605574747), 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) K150829

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-04711605574747 Basic UDI-DI 04711605574747UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04711605574747 UDI-DI Date4 Dec 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150829 Date25 Sep 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04711605574747 registered 30 Dec 2024 Active
  • FDA 510(k) K150829 decided 25 Sep 2015 Active
  • FDA GUDID UDI-DI 04711605574747 listed 4 Dec 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150829
  2. Listed FDA GUDID 04711605574747
  3. Registered EUDAMED B-04711605574747

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  • Withdrawn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

Generic name
Cruciate-retaining total knee prosthesis
Model / Ref / Catalog
2303-1216
Primary DI / UDI-DI
04711605574747
Basic UDI-DI
B-04711605574747
510(k) Number
FDA product code
JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN term
Cruciate-retaining total knee prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Height — 10 Millimeter

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.

Manufacturer details

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

Similar devices in this category

Other devices filed under BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS.

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

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