---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-020513"
form_type: "8-K"
ticker: "SINT"
cik: "0001269026"
company_name: "Sintx Technologies, Inc."
filed_at: "2025-07-22T23:59:59+00:00"
generated_at: "2026-05-18T04:09:34.782657+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001641172-25-020513
- form_type: 8-K
- ticker: SINT
- cik: 0001269026
- company_name: Sintx Technologies, Inc.
- filed_at: 2025-07-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1269026/000164117225020513/0001641172-25-020513-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1269026/000164117225020513/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-020513
- JSON: https://secwatch.observer/filing/0001641172-25-020513.json
- Plain text: https://secwatch.observer/filing/0001641172-25-020513.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.