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U2 Total Knee System

by United Orthopedic Corporation 689 variants

Ref 2303-2473-RF

U2 Total Knee System (2303-2473-RF) 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-04719872164432), cleared under FDA 510(k) K132752 on 13 Mar 2014 and listed in FDA GUDID since 22 Jun 2018 (UDI-DI 04719872164432), 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) K132752

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872164432 Basic UDI-DI 04719872164432UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872164432 UDI-DI Date22 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132752 Date13 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04719872164432 registered 10 Feb 2026 Active
  • FDA 510(k) K132752 decided 13 Mar 2014 Active
  • FDA GUDID UDI-DI 04719872164432 listed 22 Jun 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132752
  2. Listed FDA GUDID 04719872164432
  3. Registered EUDAMED B-04719872164432

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  • Withdrawn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
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
2303-2473-RF
Primary DI / UDI-DI
04719872164432
Basic UDI-DI
B-04719872164432
510(k) Number
FDA product code
JWH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class IIa 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
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)