Tenon Medical - FDA 510(k) Cleared Devices

Tenon Medical, is an orthopedic device company based in Los Gatos, California. The company specializes in sacroiliac joint fusion solutions, delivering innovative surgical options for patients with chronic sacroiliac joint pain.

Tenon Medical has received 2 FDA 510(k) clearances from 2 total submissions since 2025. The company's regulatory portfolio is entirely focused on orthopedic devices. The latest clearance was issued in 2026, reflecting active development and market engagement.

The company's flagship product is the CATAMARAN™ SI Joint Fusion System, a single-implant solution using an inferior-posterior surgical approach. The system features a titanium fixation device designed to transfix the sacroiliac joint while avoiding critical neural and vascular structures. Clinical data from the MAINSAIL Study demonstrated an 80% success rate, 61% pain reduction, and 93% patient satisfaction at six months, with no serious device-related adverse events.

Explore Tenon Medical's cleared device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant.