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U2 Total Knee System

by United Orthopedic Corporation 689 variants

Ref 2803-6143

U2 Total Knee System (2803-6143) 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-04719872166535), cleared under FDA 510(k) K161705 on 16 Mar 2017 (2 earlier submissions) and listed in FDA GUDID since 26 May 2017 (UDI-DI 04719872166535), 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

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872166535 Basic UDI-DI 04719872166535UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872166535 UDI-DI Date26 May 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-04719872166535 registered 10 Feb 2026 Active
  • FDA 510(k) K161705 decided 16 Mar 2017 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04719872166535 listed 26 May 2017 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K122183
  2. Cleared FDA 510(k) K161360
  3. Cleared FDA 510(k) K161705
  4. Listed FDA GUDID 04719872166535
  5. Registered EUDAMED B-04719872166535

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  • Withdrawn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
U2 Total Knee System EUDAMED
U2™ Knee GUDID
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
2803-6143
Primary DI / UDI-DI
04719872166535
Basic UDI-DI
B-04719872166535
510(k) Number
FDA product code
OIY, JWH, MBH
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, 888.3565
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)