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U2 Acetabular Components

by United Orthopedic Corporation 196 variants

Ref 1403-1756

U2 Acetabular Components (1403-1756) 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 27 Dec 2024 (Basic UDI-DI B-04712771483512), cleared under FDA 510(k) K111546 on 1 Jul 2011 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04712771483512), active as of 24 Oct 2026. One FDA recall is 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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111546

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-04712771483512 Basic UDI-DI 04712771483512UDI-DIDate27 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712771483512 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111546 Date1 Jul 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04712771483512 registered 27 Dec 2024 Active
  • FDA 510(k) K111546 decided 1 Jul 2011 Active
  • FDA GUDID UDI-DI 04712771483512 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1382-2013 FDA Class II initiated 20 Feb 2013

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Timeline

4 dated events

  1. Cleared FDA 510(k) K111546
  2. Recall initiated FDA recalls Z-1382-2013
  3. Listed FDA GUDID 04712771483512
  4. Registered EUDAMED B-04712771483512

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  • Withdrawn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 Acetabular Components EUDAMED
U2 Acetabular Components, XPE Cup Liner GUDID
Generic name
Metal-on-polyethylene total hip prosthesis
Device name
U2 Acetabular Components XPE Cup Liner, 0 Degree, 36mm I.D., 56mm O.D.
Model / Ref / Catalog
1403-1756
Primary DI / UDI-DI
04712771483512
Basic UDI-DI
B-04712771483512
510(k) Number
FDA product code
LPH, JDI
EMDN code
P090803040101 Standard polyethylene hip prostheses inserts
GMDN term
Metal-on-polyethylene total hip prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3358, 888.3350
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 56 Millimeter
Lumen/Inner Diameter — 36 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

Related devices

Category: Non-constrained polyethylene acetabular liner

Similar devices in this category

Other devices filed under STANDARD POLYETHYLENE HIP PROSTHESES 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)