Class Class II
Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634)
Description
Maxx Libertas Bipolar Hip Head (Bipolar Hip) by Maxx Orthopedics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243634
Clearance Date2025-08-25
Clearance TypeTraditional
Product CodeKWY
Regulation Number888.3390
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243634
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. Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K100761 | BIOPRO POLAR HEAD | Biopro, Inc. | 2010 |
Trace the full predicate network for K243634
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.