CATAMARAN SI Joint Fusion System— 510(k) K260477

Name: FDA 510(k) clearance K260477
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Substantially Equivalent

Tenon Medical

FDA 510(k) clearance K260477 for CATAMARAN SI Joint Fusion System, Substantially Equivalent on 2026-04-08. Applicant: Tenon Medical. Device class: 2.

Clearance details

Applicant: Tenon Medical
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-02-12
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28
K251365 — OptumSI Implant System2025-11-20

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K250403 — Catamaran SI Joint Fusion System2025-03-21

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.