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U2™ Hip 1201-2028-RB

by United Orthopedic Corp.

Ref 1201-2028-RB

U2™ Hip 1201-2028-RB 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 5 Feb 2026 (Basic UDI-DI B-04719872159209), cleared under FDA 510(k) K111546 on 1 Jul 2011 and listed in FDA GUDID since 16 May 2017 (UDI-DI 04719872159209), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872159209 Basic UDI-DI 04719872159209UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872159209 UDI-DI Date16 May 2017ListedStatusListed 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-04719872159209 registered 5 Feb 2026 Active
  • FDA 510(k) K111546 decided 1 Jul 2011 Active
  • FDA GUDID UDI-DI 04719872159209 listed 16 May 2017 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 04719872159209
  4. Registered EUDAMED B-04719872159209

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  • Withdrawn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
U1 Hip System EUDAMED
U2™ Hip GUDID
Generic name
Femoral head prosthesis trial
Device name
Femoral head trial, Ø28mm, -3mm
Model / Ref / Catalog
1201-2028-RB
Primary DI / UDI-DI
04719872159209
Basic UDI-DI
B-04719872159209
510(k) Number
FDA product code
JDI, LPH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Femoral head prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3358
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.

Related devices

Category: Femoral head prosthesis trial

Cleared under the same submission (K111546)

and 8 more cleared under K111546

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)