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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 / K260921

510(k) cleared

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Tigon Medical · Apr 21, 2026 · K260921

FDA cleared the Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line from Tigon Medical on Apr 21, 2026 under K260921, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 19, 2026. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

Tigon Medical has one other decision in the tracker over the last 12 months: K252596 (Tigon Medical Knotless and Dual Javelin All-Suture Anchors).

Questions & Answers

What did FDA clear under K260921?

K260921 is the FDA 510(k) for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line, submitted by Tigon Medical. FDA's decision date was Apr 21, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

Tigon Medical, based in Millersville, MD, is the applicant of record for K260921.

How long did the K260921 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Apr 21, 2026, 33 days later.

← All decisions in April 2026

Sources