Cleared Traditional

K251655 - VersaCoat Tendon Protector (VTP-44G2) (FDA 510(k) Clearance)

Also includes:
VersaCoat Tendon Protector (VTP-12G1)

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

K251655 · Alafair Biosciences · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
49d
Days
Class 2
Risk

K251655 is an FDA 510(k) clearance for the VersaCoat Tendon Protector (VTP-44G2). Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by Alafair Biosciences (Austin, US). The FDA issued a Cleared decision on July 18, 2025 after a review of 49 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 Alafair Biosciences devices

Submission Details

510(k) Number K251655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2025
Decision Date July 18, 2025
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
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.

Regulatory Peers - OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

All 9
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