Class Class II
Origin™ Cemented Hip Stem (K243043)
Description
Origin™ Cemented Hip Stem by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243043
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243043
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. Origin™ Cemented Hip Stem (K243043) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201951 | Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020 |
| K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, ... | Signature Orthopaedics Pty Limited | 2014 |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR... | Signature Orthopaedics Pty, Ltd. | 2012 |
Trace the full predicate network for K243043
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.