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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 / June 2026 / K261621

510(k) cleared

TekBrace Solo Soft Tissue Reinforcement Device

Theramicro · Jun 9, 2026 · K261621

FDA cleared the TekBrace Solo Soft Tissue Reinforcement Device from Theramicro on Jun 9, 2026 under K261621, a special 510(k). The device falls under product code QUW, Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 15, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

Theramicro has one other decision in the tracker over the last 12 months: K253538 (TeKBrace Knotless Anchor).

Questions & Answers

What did FDA clear under K261621?

K261621 is the FDA 510(k) for TekBrace Solo Soft Tissue Reinforcement Device, submitted by Theramicro. FDA's decision date was Jun 9, 2026, under product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament).

Who makes the TekBrace Solo Soft Tissue Reinforcement Device?

Theramicro, based in Cordova, TN, is the applicant of record for K261621.

How long did the K261621 review take?

FDA received the submission on May 15, 2026 and issued its decision on Jun 9, 2026, 25 days later.

← All decisions in June 2026

Sources