Class Class II
Kinos Total Ankle System (K241482)
Description
Kinos Total Ankle System by Restor3d, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241482
Clearance Date2024-07-22
Clearance TypeTraditional
Product CodeHSN
Regulation Number888.3110
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241482
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. Kinos Total Ankle System (K241482) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023 |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020 |
| K113828 | DYNANAIL ANKLE ARTHRODESIS NAIL | MedShape, Inc. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242868 | Kinos Total Ankle System | Restor3D | 2024 |
Trace the full predicate network for K241482
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.