Incompass Total Ankle System

The Incompass Total Ankle System is a total ankle replacement device designed to reduce pain, restore alignment, and restore flexion/extension movement in damaged ankle joints. It is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, and for patients with failed previous ankle surgery. The device consists of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes, and is intended for cement use only in the United States.

The Incompass system harmonizes the Infinity and Inbone Total Ankle Systems into one comprehensive system by sharing the same tibial resection geometry between pegged and stemmed tibial tray designs. The subject and predicate implants have similar materials, design features, instrumentation, and performance characteristics, with technological differences supported by verification and validation evaluations.

Not stated in this summary.

The device shares identical intended use, general design features, and basic fundamental scientific technology with its predicate devices (Inbone, Infinity, and Invision Total Ankle Systems). Non-clinical bench testing demonstrated substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety. The design differences do not raise new questions of safety or effectiveness and are supported by performance testing and process validation.