Sintx Technologies has earned FDA 510(k) clearance for its SINAPTIC Foot & Ankle Osteotomy Wedge System.
The implant system combines a silicon nitride biomaterial, surgeon-informed implant designs and a single-use instrument kit, according to an Oct. 20 news release from the company.
Sintx aims to increase surgical efficiency, precision and predictability with its implant system.
The company is planning a U.S. commercial launch in the first quarter of 2026, the release said.
