07:35 AM EDT, 10/20/2025 (MT Newswires) -- Sintx Technologies ( SINT ) said Monday its Sinaptic foot and ankle osteotomy wedge system received 510(k) clearance from the US Food and Drug Administration.

The implant system combines silicon nitride biomaterial with surgeon-informed implant designs for foot and ankle reconstructive surgery.

Sintx ( SINT ) said it plans a US commercial launch in Q1.

The company's shares were up nearly 11% in recent premarket activity.