Cleared Traditional

TekBrace Solo Soft Tissue Reinforcement Device

K251063 · Theramicro · Orthopedic
May 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K251063 is an FDA 510(k) clearance for the TekBrace Solo Soft Tissue Reinforcement Device, a Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (Class II — Special Controls, product code QUW), submitted by Theramicro (Cordova, US). The FDA issued a Cleared decision on May 30, 2025, 56 days after receiving the submission on April 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K251063 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2025
Decision Date May 30, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code QUW — Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair.