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OR3O Dual Mobility System

by Smith & Nephew, Inc. 3 variants

510(k) K220959

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK220959 Date18 Aug 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 25 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 OR3O Dual Mobility System is a modular orthopedic device designed for use in patients at risk of instability following total hip arthroplasty. It incorporates diffusion-hardened bearing technology and oxidized zirconium material to provide a dual mobility articulation.

This system is supplied as a modular construct for surgical implantation. It has received FDA 510(k) clearance as a substantially equivalent orthopedic device.

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Questions

AI-generated answers, 25 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 is the primary clinical purpose of the OR3O Dual Mobility System?

    This system is designed for use in patients who are at risk of instability following a total hip arthroplasty procedure. It utilizes a dual mobility articulation to help address these stability concerns.

  • What materials are used in the construction of this hip system?

    The OR3O Dual Mobility System incorporates oxidized zirconium material and diffusion-hardened bearing technology to create its modular construct.

  • How is the OR3O Dual Mobility System supplied for clinical use?

    The device is supplied as a modular construct intended for surgical implantation during orthopedic procedures.

  • What is the regulatory status of the OR3O Dual Mobility System?

    The OR3O Dual Mobility System has received FDA 510(k) clearance as a substantially equivalent orthopedic device under the K220959 submission.