REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (K242377)
Description
REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component by Osteoremedies, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242377
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. REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (K242377) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223650 | REMEDY Stemmed Knee Spacer | Osteoremedies, LLC | 2023 |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 |
Trace the full predicate network for K242377
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.