Cleared Traditional

Tendon Protect (50242)

K243843 · Kerecis Limited · Orthopedic

Jun 2025

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K243843 is an FDA 510(k) clearance for the Tendon Protect (50242), a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on June 4, 2025, 173 days after receiving the submission on December 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K243843 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2024
Decision Date	June 04, 2025
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWY — Mesh, Surgical, Collagen, 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 In Tendon Repair.