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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 / K253538

510(k) cleared

TeKBrace Knotless Anchor

Theramicro · Mar 6, 2026 · K253538

FDA cleared the TeKBrace Knotless Anchor from Theramicro on Mar 6, 2026 under K253538, 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 Nov 13, 2025. The decision came 113 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Theramicro has one other decision in the tracker over the last 12 months: K261621 (TekBrace Solo Soft Tissue Reinforcement Device).

Questions & Answers

What did FDA clear under K253538?

K253538 is the FDA 510(k) for TeKBrace Knotless Anchor, submitted by Theramicro. FDA's decision date was Mar 6, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the TeKBrace Knotless Anchor?

Theramicro, based in Cordova, TN, is the applicant of record for K253538.

How long did the K253538 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Mar 6, 2026, 113 days later.

← All decisions in March 2026

Sources