Cleared Traditional

Collagen Meniscus Implant XL

K170364 · Ivy Sports Medicine, LLC · Orthopedic
May 2017
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K170364 is an FDA 510(k) clearance for the Collagen Meniscus Implant XL, a Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen (Class II — Special Controls, product code OLC), submitted by Ivy Sports Medicine, LLC (Redwood City, US). The FDA issued a Cleared decision on May 2, 2017, 85 days after receiving the submission on February 6, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K170364 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2017
Decision Date May 02, 2017
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition Intended For Use In Surgical Procedures For The Repair And Reinforcement Of Soft Tissue Injuries Of The Medial Meniscus. In Repairing And Reinforcing Medial Meniscal Defects, The Patient Must Have An Intact Meniscal Rim And Anterior And Posterior Horns For Attachment Of The Mesh. In Addition, The Surgically Prepared Site Must Extend At Least Into The Red/white Zone Of The Meniscus To Provide Sufficient Vascularization. The Device Reinforces Soft Tissue And Provides A Resorbable Scaffold That Is Replaced By The Patients Own Soft Tissue. The Device Is Not A Prosthetic Device And Is Not Intended To Replace Normal Body Structure.