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United U2 Hip Stem

by United Orthopedic Corporation EUDAMEDGUDID

Active European Union and United States

Ref 1104-1412, 9104-3212, 1104-1214, 9104-6380, 1104-1216, 1104-3278, 1104-3034, 1104-2214-RB, 9104-3618, 9104-3520, 1104-1712, 9104-6000-RC, 1104-2215-RB, 1104-1316, 1104-5256

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-04712602340519 Basic UDI-DIDate27 Dec 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-04712602340519 Basic UDI-DIDate27 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712602340519 UDI-DIDate24 Oct 2015ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

Specification

EUDAMED · GUDID

Trade Name
United U2 Hip Stem EUDAMED
U2 Hip Stem EUDAMEDGUDID
U2 Hip Stem, Revision Hip Stem With Collar, Straight GUDID
U2™ Hip GUDID
U2 Hip Stem, Ti Porous Coated GUDID
U2 Hip Stem, Cemented GUDID
U2 Hip Stem, Revision Hip Stem With Collar, Curved GUDID
U2 Hip Stem, Ti Porous Coated, Matrix GUDID
U2 Hip Stem, Revision Hip Stem Collarless, Curved GUDID
Generic Name
Metal-on-polyethylene total hip prosthesis
Medullary canal orthopaedic reamer, flexible
Orthopaedic broach
Medullary canal orthopaedic reamer, rigid
Revision coated hip femur prosthesis
Femoral stem prosthesis trial
Device Name
U2 Hip Stem Revision Hip Stem, With Collar, Curved, 12mm Dia., 230mm Stem Length, Right
U2 Hip Stem Revision Hip Stem, With Collar, Straight, 14mm Dia., 180mm Stem Length
United Hip and Knee Non-sterile Reusable Instruments
U2 Hip Stem Revision Hip Stem, With Collar, Straight, 16.5mm Dia., 180mm Stem Length
U2 Hip Stem Ti Porous Coated, Matrix, #7 Proximal, 15mm Dia. Distal
U2 Hip Stem Ti Porous Coated, #3 Proximal, 11mm Dia. Distal
U2 Hip Stem Revision Hip Stem, Collarless, Curved, 12mm Dia., 230mm Stem Length, Left
U2 Hip Stem Revision Hip Stem, With Collar, Curved, 16.5mm Dia., 230mm Stem Length, Left
U2 Hip Stem Cemented, #5 Proximal, 13mm Dia. Distal
Model / Ref / Catalog
1104-1412, 1104-1214, 9104-3618, 1104-3034, 1104-5256, 9104-6000-RC, 1104-1316, 9104-6380, 9104-3212, 1104-3278, 9104-3520, 1104-2214-RB, 1104-2215-RB, 1104-1712, 1104-1216
Primary DI / UDI-DI
04712602340519, 04712602340397, 04719872172246, 04712602340809, 04712602340953, 04719872166870, 04712602340489, 04719872167136, 04719872171935, 04712771495874, 04719872172109, 04719872158776, 04719872158790, 04712602340656, 04712602340410
Basic UDI-DI
B-04712602340519, B-04719872171935, B-04712602340397, 471987216TD-Ir-003F4, B-04712602340410, B-04712771495874, B-04712602340809, B-04719872158776, B-04719872172246, B-04719872172109, B-04712602340656, B-04719872158790, B-04712602340489, B-04712602340953
Direct Marketing DI
04719872167136
04719872166870
510(k) Number
FDA Product Code
LWJ, HTO, LPH, MEH, JDI
EMDN Code
P090804030201, L091102, L091202, P090804010201, L091199, P090804010101
GMDN Term
Metal-on-polyethylene total hip prosthesis
Medullary canal orthopaedic reamer, flexible
Orthopaedic broach
Medullary canal orthopaedic reamer, rigid
Revision coated hip femur prosthesis
Femoral stem prosthesis trial
Device Class
Class III EUDAMED
Class I EUDAMEDGUDID
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.4540, 888.3358, 888.3353, 888.3350
Market of Registration
France
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
Class I
Class IIa
GUDID
Class I
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000009523
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Sterile YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Single Use YesGUDIDNoGUDID
  • Implantable YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID
  • Manufacturing Date NoGUDIDYesGUDID

Other properties (15)

  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No