Class Class II
ATTUNE® Revision Cones (K230295)
Description
ATTUNE® Revision Cones by Depuy Ireland UC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230295
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeMBH
Regulation Number888.3565
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230295
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. ATTUNE® Revision Cones (K230295) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LP... | Depuy Ireland UC | 2024 |
Trace the full predicate network for K230295
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.