Class Class II
Longboard Revision Hip Stem (K243021)
Description
Longboard Revision Hip Stem by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243021
Clearance Date2025-08-07
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243021
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. Longboard Revision Hip Stem (K243021) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020 |
| K192883 | Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020 |
| K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR... | Signature Orthopaedics Pty, Ltd. | 2012 |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | 2010 |
Trace the full predicate network for K243021
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.