Class Class II
Rx Knee System (K240683)
Description
Rx Knee System by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240683
Clearance Date2024-09-11
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240683
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. Rx Knee System (K240683) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223062 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2022 |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), W... | Signature Orthopaedics Pty, Ltd. | 2022 |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2018 |
| K160700 | ATTUNE Revision Knee System | Depuy(Ireland) | 2016 |
Trace the full predicate network for K240683
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.