Skip to content

SignaSure Dual Mobility System

by Signature Orthopaedics Pty Ltd 2 variants

510(k) K211742

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 NumberK211742 Date7 Jan 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  • Withdrawn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
MEH
FDA applicant
Signature Orthopaedics Pty, Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3353
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 SignaSure Dual Mobility System is a prosthesis for the hip, classified as semi-constrained, uncemented, and made of metal/polymer with non-porous calcium phosphate components. This device is designed to provide mobility and stability in hip replacement procedures.

The system is supplied by Signature Orthopaedics Pty, Ltd. and is regulated under FDA 510(k) clearance with product code MEH. It received a 'Substantially Equivalent' decision on January 7, 2022, after being received by the FDA on June 7, 2021. The device is intended for orthopedic use and is available in various sizes as specified by the manufacturer.

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →

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 SignaSure Dual Mobility System used for?

    The SignaSure Dual Mobility System is designed to provide mobility and stability in hip replacement procedures, intended for orthopedic use.

  • How is the SignaSure Dual Mobility System supplied?

    The system is supplied by Signature Orthopaedics Pty, Ltd. and is available in various sizes as specified by the manufacturer.

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

    The device received a 'Substantially Equivalent' decision under FDA 510(k) clearance with product code MEH on January 7, 2022.