Cleared Traditional

Integrity Implant

K223538 · Anika Therapeutics, Inc. · Orthopedic

Aug 2023

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K223538 is an FDA 510(k) clearance for the Integrity Implant, a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II — Special Controls, product code OWX), submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on August 17, 2023, 267 days after receiving the submission on November 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K223538 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2022
Decision Date	August 17, 2023
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWX — Mesh, Surgical, Non-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 In Tendon Repair.