Cleared Traditional

Integrity? Implant

K250997 · Anika Therapeutics, Inc. · Orthopedic

Jun 2025

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K250997 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 June 17, 2025, 77 days after receiving the submission on April 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K250997 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2025
Decision Date	June 17, 2025
Days to Decision	77 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.