SINTX submits FDA 510(k) for silicon nitride foot/ankle implants, entering $750M market

Sintx Technologies, Inc.

Filed 510(k) for silicon nitride osteotomy wedges on July 22, 2025, targeting foot/ankle fusion.
Foot/ankle fusion market valued at $750.5M, projected to reach $1.38B by 2032.
Biomaterial track record: >50,000 spinal implants since 2008; antimicrobial & radiolucent properties.
Implants to be manufactured at SINTX's FDA/ISO facility, distributed as SiNAPTIC Surgical (acquired July 1, 2025).
Expected to drive revenue growth through hospital and ASC adoption with single-use instrumentation.

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