Maxx Libertas Bipolar Hip Head (Bipolar Hip)

The Maxx Libertas Bipolar Hip Head is a hip replacement component consisting of a cobalt chromium outer shell, UHMWPE liner, and UHMWPE retention ring. It is used with the Maxx Libertas femoral stem for uncemented primary or revision hip replacement to treat femoral neck fractures, trochanteric fractures, osteonecrosis of the femoral head, and revision cases where prior treatments have failed.

The subject device is identical to the predicate device (BioPro Bipolar Head, K100761) in design, material composition, chemical composition, and principle of operation. Both devices feature a polished spherical outer surface, hemispherical liner for articulation with a 28 mm femoral head, and a retention ring to prevent dislocation.

Not stated in this summary.

The device achieves substantial equivalence through design and material identity with the predicate device. Mechanical testing demonstrated identical performance to the predicate in range of motion, static push-out, and static lever-out tests. Engineering analysis for impingement scenarios supported equivalence. Since the subject device is materially and functionally identical to the predicate device and the indications for use are the same, the FDA concluded substantial equivalence is supported.