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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 / December 2025 / K252596

510(k) cleared

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

Tigon Medical · Dec 4, 2025 · K252596

FDA cleared the Tigon Medical Knotless and Dual Javelin All-Suture Anchors from Tigon Medical on Dec 4, 2025 under K252596, a traditional 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 Aug 15, 2025. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tigon Medical has one other decision in the tracker over the last 12 months: K260921 (Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line).

Questions & Answers

What did FDA clear under K252596?

K252596 is the FDA 510(k) for Tigon Medical Knotless and Dual Javelin All-Suture Anchors, submitted by Tigon Medical. FDA's decision date was Dec 4, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Tigon Medical Knotless and Dual Javelin All-Suture Anchors?

Tigon Medical, based in Millersville, MD, is the applicant of record for K252596.

How long did the K252596 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Dec 4, 2025, 111 days later.

← All decisions in December 2025

Sources