APEX 3D Total Ankle Replacement System

The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing prosthetic device used for total ankle replacement in primary and revision surgery for patients with severe rheumatoid, post-traumatic, or degenerative ankle arthritis. It comprises a tibial component, a talar component, and a UHMWPE (ultra-high molecular weight polyethylene) component, with multiple sizes and configurations available for patient-specific fit.

The subject device introduces a new diffusion-bonded talar dome component to the existing APEX 3D system. The raw materials in the subject talar dome are identical to materials in the primary predicate device components. The manufacturing difference is the diffusion bonding method used for the talar dome, which is the same manufacturing method employed by the additional predicate device (Zimmer Trabecular Metal Total Ankle).

Not stated in this summary.

Substantial equivalence is established through identical indications for use and similar technological characteristics to the primary predicate (K192994). Although the subject device uses diffusion bonding as a manufacturing method (differing from the primary predicate's manufacturing approach), this method is already established and used in the additional predicate device. The raw materials are identical to those in the primary predicate, and nonclinical performance testing (tensile strength, shear strength, fatigue, abrasion resistance, corrosion) demonstrated that the manufacturing difference does not introduce different questions of safety and effectiveness.