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U-Motion II Acetabular System-Extension line

by United Orthopedic Corporation

510(k) K221149

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

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) K221149↗

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 NumberK221149 Date5 Jan 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
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  • Withdrawn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/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 U-Motion II Acetabular System Extension Line is a modular acetabular component designed for total hip arthroplasty. It provides customizable options for acetabular cup placement, including various sizes and orientations to accommodate diverse anatomical requirements and surgical approaches.

This system is intended for use in orthopedic surgical settings and is supplied as a reusable or single-use device, depending on the specific components. The extension line adheres to FDA 510K clearance, MDD, and MDR regulatory standards, ensuring compliance with international medical device directives. Components are available in predefined sizes and configurations, with sterility maintained through manufacturer-provided packaging.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of surgical approaches does the U-Motion II Acetabular System Extension Line support, and how does its modularity help in customization?

    The U-Motion II Acetabular System Extension Line is designed to accommodate diverse anatomical requirements and surgical approaches in total hip arthroplasty. Its modularity allows for customizable acetabular cup placement, including various sizes and orientations, ensuring flexibility to match the patient’s anatomy and the surgeon’s preferred technique. This adaptability helps optimize fit, stability, and alignment during surgery.

  • Is the U-Motion II Acetabular System Extension Line available as a single-use or reusable device, and how is sterility ensured?

    The U-Motion II Acetabular System Extension Line can be supplied as either reusable or single-use, depending on the specific components selected. Sterility is maintained through manufacturer-provided packaging, ensuring components meet regulatory standards for cleanliness and safety before use.

  • What regulatory standards does the U-Motion II Acetabular System Extension Line comply with, and how does this affect its use in clinical settings?

    The system complies with FDA 510K clearance, as well as the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. This ensures it meets international requirements for safety, performance, and quality, giving clinicians confidence in its use for total hip arthroplasty procedures.

  • How are the components of the U-Motion II Acetabular System Extension Line sized, and what does this mean for surgical planning?

    The U-Motion II Acetabular System Extension Line comes in predefined sizes and configurations, allowing surgeons to select the optimal cup dimensions and orientations for each patient. This pre-defined sizing simplifies surgical planning by ensuring compatibility with anatomical variations and preferred implant positioning, reducing intraoperative adjustments.