Biolox® Delta Revision heads

The Biolox® Delta Revision heads are femoral head components used in total hip arthroplasty (hip replacement) for patients with degenerative joint disease, arthritis, fractures, or failed previous hip replacements. They consist of a ceramic ball head (Biolox® Delta material) assembled with a titanium sleeve, designed to articulate against an acetabular insert and couple with various femoral stems.

The device uses the same Biolox® Delta ceramic material, manufacturing methods, fixation design, and product codes as the predicate devices. It employs a 12/14 taper press-fit design on the inner surface to connect to the femoral stem and a 16/18 taper on the outer surface to accommodate the ball head. Titanium sleeves are available in four sizes (-3, 0, +4, +7) with ball head outer diameters ranging 28–40 mm.

ISO 7206-10 (burst, fatigue, post-fatigue, pull-off testing), ASTM F1875 (fretting corrosion), ASTM F2009 (pull-off), ISO 7206-13 (torque-off), ISO 7206-4 (fatigue mechanical evaluation), and ISO 7206-6 (fatigue-fretting mechanical evaluation).

The subject device is substantially equivalent because it uses identical materials, manufacturing processes, design class, and regulatory classification as the predicate devices (TJO Biolox® Option Ceramic Heads Line Extension and Biomet UK Biolox® Delta Option Ceramic Heads). Mechanical testing on worst-case configurations demonstrates equivalent performance, and the device dimensions match previously cleared LimaCorporate femoral heads with the same taper fit and articulation surfaces.