Cleared Traditional

REGENETEN? Bioinductive Implant

K242631 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic
Nov 2024
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K242631 is an FDA 510(k) clearance for the REGENETEN? Bioinductive Implant, a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWY), submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on November 26, 2024, 84 days after receiving the submission on September 3, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K242631 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2024
Decision Date November 26, 2024
Days to Decision 84 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.