Class Class II
RECLAIM Monobloc Revision Femoral Stem (K251292)
Description
RECLAIM Monobloc Revision Femoral Stem by Depuy Ireland UC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251292
Clearance Date2025-05-23
Clearance TypeSpecial
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251292
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. RECLAIM Monobloc Revision Femoral Stem (K251292) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePu... | Depuy Ireland UC | 2024 |
| K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | Depuy Ireland UC | 2022 |
Trace the full predicate network for K251292
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.