Cleared Traditional

TeKBrace Knotless Anchor

K253538 · Theramicro · Orthopedic

Mar 2026

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K253538 is an FDA 510(k) clearance for the TeKBrace Knotless Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Theramicro (Cordova, US). The FDA issued a Cleared decision on March 6, 2026, 113 days after receiving the submission on November 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K253538 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2025
Decision Date	March 06, 2026
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF