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U2 Total Knee System

by United Orthopedic Corporation 704 variants

Ref 2303-1828

U2 Total Knee System (2303-1828) 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-04719872151074), cleared under FDA 510(k) K161705 on 16 Mar 2017 and listed in FDA GUDID since 23 Mar 2017 (UDI-DI 04719872151074), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161705

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872151074 Basic UDI-DI 04719872151074UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872151074 UDI-DI Date23 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK161705 Date16 Mar 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04719872151074 registered 30 Dec 2024 Active
  • FDA 510(k) K161705 decided 16 Mar 2017 Active
  • FDA GUDID UDI-DI 04719872151074 listed 23 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161705
  2. Listed FDA GUDID 04719872151074
  3. Registered EUDAMED B-04719872151074

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  • Withdrawn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
Device name
U2 Total Knee System E-XPE Tibial Insert, Cruciate Retaining, #2, 14mm Thick
Model / Ref / Catalog
2303-1828
Primary DI / UDI-DI
04719872151074
Basic UDI-DI
B-04719872151074
510(k) Number
FDA product code
JWH, MBH, OIY
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, 888.3565
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.

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)