FDA.reportPublic FDA data

510(k) K220495

Device
SignaSure Dual Mobility System
Applicant
Signature Orthopaedics Pty, Ltd.
510(k) number
K220495
Product code
MEH
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-13
Date received
2022-02-22
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Declan Brazil
Address
7 Sirius Rd. Lane Cove West AU 2066 2066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG2025-11-05
K251166Mfinity Femoral SystemMedacta International S.A.2025-06-13
K251052Trivicta® Hip StemOrtho Development Corp.2025-05-22
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation2025-05-01
K243839Alteon® HA Femoral StemsExactech, Inc.2025-03-10
K243162World LinerSignature Orthopaedics Pty, Ltd.2024-11-25
K241472Icona Hip StemCorin U.S.A. Limited2024-10-03
K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix2024-09-13
K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.2024-08-01
K233758Trivicta™ Hip StemOrtho Development Corp.2024-03-08
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalDepuy Ireland UC2024-01-19
K231178ACTERA™ hip systemConformis, Inc.2023-05-23
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022-08-11
K221104Actera™ hip systemConformis, Inc.2022-08-04
K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.2022-01-07