Cleared Traditional

K251063 - TekBrace Solo Soft Tissue Reinforcement Device (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K251063 is an FDA 510(k) clearance for the TekBrace Solo Soft Tissue Reinforcement Device. Classified as Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (product code QUW), Class II - Special Controls.

Submitted by Theramicro (Cordova, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theramicro devices

Submission Details

510(k) Number K251063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUW Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.