Cleared Traditional

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)

K251655 · Alafair Biosciences · Orthopedic

Jul 2025

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K251655 is an FDA 510(k) clearance for the VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1), a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWW), submitted by Alafair Biosciences (Austin, US). The FDA issued a Cleared decision on July 18, 2025, 49 days after receiving the submission on May 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K251655 FDA.gov
FDA Decision	Cleared 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

Device Classification

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