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Curved stem, PSA type, Cemented 2703-5231

by United Orthopedic Corp.

Ref 2703-5231

Curved stem, PSA type, Cemented 2703-5231 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-04712771481105), cleared under FDA 510(k) K082424 on 16 Dec 2008 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04712771481105), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082424

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-04712771481105 Basic UDI-DI 04712771481105UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712771481105 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK082424 Date16 Dec 2008IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04712771481105 registered 30 Dec 2024 Active
  • FDA 510(k) K082424 decided 16 Dec 2008 Active
  • FDA GUDID UDI-DI 04712771481105 listed 24 Oct 2015 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2883-2026 FDA Class II initiated 20 May 2026

    Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

    • Terminated Z-1129-2018 FDA Class II initiated 24 Nov 2017

    UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

Timeline

5 dated events

  1. Cleared FDA 510(k) K082424
  2. Listed FDA GUDID 04712771481105
  3. Recall initiated FDA recalls Z-1129-2018
  4. Registered EUDAMED B-04712771481105
  5. Recall initiated FDA recalls Z-2883-2026

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
Curved stem, PSA type, Cemented GUDID
Generic name
Posterior-stabilized total knee prosthesis
Device name
U2 Total Knee System Curved Stem, PSA, Cemented, 10mm Dia., 150mm Stem Length
Model / Ref / Catalog
2703-5231
Primary DI / UDI-DI
04712771481105
Basic UDI-DI
B-04712771481105
510(k) Number
FDA product code
JWH
EMDN code
P0909800601, P0909800602
GMDN term
Posterior-stabilized 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
Length — 150 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.

Related devices

Category: Posterior-stabilized total knee prosthesis

Cleared under the same submission (K082424)

and 8 more cleared under K082424

Similar devices in this category

Other devices filed under KNEE PROSTHESES FEMORAL STEMS.

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)