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United Hip System

by United Orthopedic Corporation 256 variants

Ref 1306-3060

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04712771502541 Basic UDI-DI 04712771502541UDI-DIDate27 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712771502541 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

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

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
United Hip System EUDAMED
United Hip System, U-Motion II PS Cup,Cluster-Hole GUDID
Generic Name
Ceramic-on-ceramic total hip prosthesis
Device Name
United Hip System U-Motion II PS Cup, Cluster-Hole, 60mm O.D.
Model / Ref / Catalog
1306-3060
Primary DI / UDI-DI
04712771502541
Basic UDI-DI
B-04712771502541
510(k) Number
FDA Product Code
LZO, KWY, LWJ, JDI, MEH, OQI
EMDN Code
P090803010201 Primary implant uncemented metal acetabular cups
GMDN Term
Ceramic-on-ceramic total hip prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3390, 888.3360, 888.3350
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 60 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
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
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No