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U2 Hip System

by United Orthopedic Corporation

510(k) K130149

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130149↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130149 Date6 Jun 2013ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 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  • Withdrawn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 · 510(k)

Full name
U2 Hip System, Expanded Indications for Use
510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The U2 Hip System is a modular orthopedic implant designed for total hip arthroplasty, featuring a femoral stem and acetabular components intended to restore function and alleviate pain in patients with degenerative joint disease or hip fractures. It is classified under the product code LPH, reflecting its use in hip replacement procedures with expanded indications for patient suitability.

This system is supplied as a sterile, single-use device intended for surgical use in accredited orthopedic facilities. Components are available in various sizes to accommodate different patient anatomies, and the system has received FDA 510(k) clearance and conforms to the Medical Device Directive (MDD). No MRI safety information or reusable components are specified in the regulatory data.

From the manufacturer

Femoral Component, PF+, Tibial. Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.

Source: unitedorthopedic.com

hip arthroplasty using United Orthopedics' Conformity stem. Page 4. United Orthopedic. Conformity Stem. IV. V. Surgical Overview. A. Femoral Osteotomy. F.

Source: unitedorthopedic.com

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