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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K260477

510(k) cleared

CATAMARAN SI Joint Fusion System

Tenon Medical · Apr 8, 2026 · K260477

FDA cleared the CATAMARAN SI Joint Fusion System from Tenon Medical on Apr 8, 2026 under K260477, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 12, 2026. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Tenon Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260477?

K260477 is the FDA 510(k) for CATAMARAN SI Joint Fusion System, submitted by Tenon Medical. FDA's decision date was Apr 8, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the CATAMARAN SI Joint Fusion System?

Tenon Medical, based in Los Gatos, CA, is the applicant of record for K260477.

How long did the K260477 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Apr 8, 2026, 55 days later.

← All decisions in April 2026