Class Class II
SignaSure Dual Mobility System (K220495)
Description
SignaSure Dual Mobility System by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220495
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220495
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SignaSure Dual Mobility System (K220495) cites 10 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Line... | Signature Orthopaedics Pty, Ltd. | 2016 |
| K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 |
| K142675 | CI../..X liner for NOVAE Dual Mobility Acetabular Cup | Serf | 2015 |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR... | Signature Orthopaedics Pty, Ltd. | 2012 |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | Howmedica Osteonics Corp. | 2011 |
| K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT T... | Serf | 2011 |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | Howmedica Osteonics Corp. | 2011 |
| K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | Howmedica Osteonics Corp. | 2009 |
| K072020 | RESTORATION ADM SYSTEM | Howmedica Osteonics Corp. | 2007 |
Trace the full predicate network for K220495
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.