510(k) K243634

Maxx Libertas Bipolar Hip Head (Bipolar Hip) by Maxx Orthopedics, Inc. — Product Code KWY

K243634 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Maxx Libertas Bipolar Hip Head (Bipolar Hip)". The FDA issued a decision of Substantially Equivalent on August 25, 2025. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.