8-K
filed July 22, 2025, 7:59 PM ET
ticker SINT
CIK 0001269026
regulatory
confidence high
sentiment positive
materiality 0.75
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.
Machine-readable event card
- 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
- discovered_at
- 2026-05-14T18:02:43.553570+00:00
- generated_at
- 2026-05-18T04:09:34.782657+00:00
- sec_items
- ["7.01", "9.01"]
- event_type
- regulatory
- sentiment
- positive
- materiality_score
- 0.75
- calibrated_materiality_score
- 0.75
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001641172-25-020513
- json_url
- https://secwatch.observer/filing/0001641172-25-020513.json
- markdown_url
- https://secwatch.observer/filing/0001641172-25-020513.md
- text_url
- https://secwatch.observer/filing/0001641172-25-020513.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1269026/000164117225020513/0001641172-25-020513-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1269026/000164117225020513/form8-k.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
- superseded_by
- null
Comparable filings
GENC
Gencor receives NYSE American delinquency notice for late Q2 2026 10-Q filing
GENCOR INDUSTRIES INC
June 1, 2026, 4:09 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
NJR
NJNG files base rate case seeking $157.6M increase; offers 8.9% winter bill cut
NEW JERSEY RESOURCES CORP
June 1, 2026, 4:03 PM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
ELTP
Elite Pharmaceuticals files ANDA for generic anticoagulant; $26B brand market, no generic available
ELITE PHARMACEUTICALS INC /NV/
June 1, 2026, 7:00 AM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
ATNM
Actinium receives NYSE American non-compliance notice for low stockholders' equity; must submit plan by June 26
Actinium Pharmaceuticals, Inc.
May 29, 2026, 5:10 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
REPL
Replimune to resubmit RP1 BLA for advanced melanoma; FDA agrees to prioritize review
Replimune Group, Inc.
May 29, 2026, 9:56 AM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
CDT
CDT Equity receives Nasdaq deficiency letter for late Q1 10-Q filing; has until July 20 to submit plan
CDT Equity Inc.
May 28, 2026, 4:30 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
BCDA
BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026
BioCardia, Inc.
May 28, 2026, 8:00 AM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
GWAV
Greenwave receives second Nasdaq delinquency notice for late Q1 2026 10-Q filing
Greenwave Technology Solutions, Inc.
May 27, 2026, 5:25 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice.
See methodology for how this pipeline works.