---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-095851"
form_type: "8-K"
ticker: "SSII"
cik: "0001676163"
company_name: "SS Innovations International, Inc."
filed_at: "2025-10-03T23:59:59+00:00"
generated_at: "2026-05-17T04:46:40.277112+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# SS Innovations completes human factors validation study for SSi Mantra; plans FDA 510(k) in Q4 2025

## Summary
- Completed human factors validation study for SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025.
- Anticipates submitting 510(k) premarket notification to FDA in Q4 2025; potential US clearance in H1 2026 if FDA approves.
- Company pivoted from De Novo request to 510(k) pathway for speed and cost advantages per FDA discussions.
- SSi Mantra cumulative installed base: 125 systems across 6 countries; 119 hospitals, over 6,000 procedures performed.

## SEC filing metadata
- accession: 0001213900-25-095851
- form_type: 8-K
- ticker: SSII
- cik: 0001676163
- company_name: SS Innovations International, Inc.
- filed_at: 2025-10-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676163/000121390025095851/0001213900-25-095851-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676163/000121390025095851/ea0260185-8k_ssinnova.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-095851
- JSON: https://secwatch.observer/filing/0001213900-25-095851.json
- Plain text: https://secwatch.observer/filing/0001213900-25-095851.txt

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