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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 / March 2026 / K252081

510(k) cleared

SportLinc Syndesmosis Device

Lincotek Medical · Mar 27, 2026 · K252081

FDA cleared the SportLinc Syndesmosis Device from Lincotek Medical on Mar 27, 2026 under K252081, a traditional 510(k). The device falls under product code HTN, Washer, Bolt Nut, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 2, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Lincotek Medical has one other decision in the tracker over the last 12 months: K250764 (SpineLinc Anterior Cervical Implant System).

Questions & Answers

What did FDA clear under K252081?

K252081 is the FDA 510(k) for SportLinc Syndesmosis Device, submitted by Lincotek Medical. FDA's decision date was Mar 27, 2026, under product code HTN (Washer, Bolt Nut).

Who makes the SportLinc Syndesmosis Device?

Lincotek Medical, based in Bartlett, TN, is the applicant of record for K252081.

How long did the K252081 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Mar 27, 2026, 268 days later.

← All decisions in March 2026

Sources