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The Tracker / August 2026 / K262729

510(k) cleared

TeKBrace Solo Soft Tissue Reinforcement Device

Theramicro · Aug 18, 2026 · K262729

FDA cleared the TeKBrace Solo Soft Tissue Reinforcement Device from Theramicro on Aug 18, 2026 under K262729, 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 Jul 31, 2026. The decision came 18 days later, inside the 90 FDA-day goal for a 510(k).

Theramicro has 2 other decisions in the tracker over the last 12 months: K261621 (TekBrace Solo Soft Tissue Reinforcement Device), K253538 (TeKBrace Knotless Anchor).

Questions & Answers

What did FDA clear under K262729?

K262729 is the FDA 510(k) for TeKBrace Solo Soft Tissue Reinforcement Device, submitted by Theramicro. FDA's decision date was Aug 18, 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 K262729.

How long did the K262729 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Aug 18, 2026, 18 days later.

← All decisions in August 2026

Sources