Cleared Traditional

Regeneten Bioinductive Implant

K222501 · Smith and Nephew, Inc. · Orthopedic

May 2023

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K222501 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 and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on May 11, 2023, 266 days after receiving the submission on August 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K222501 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2022
Decision Date	May 11, 2023
Days to Decision	266 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.