Class Class II
InterSpace GV Hip Spacer (K252326)
Description
InterSpace GV Hip Spacer by Tecres S.P.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252326
Clearance Date2025-08-06
Clearance TypeSpecial
Product CodeKWL
Regulation Number888.3360
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252326
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. InterSpace GV Hip Spacer (K252326) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018 |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | 2004 |
Trace the full predicate network for K252326
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.