Cleared Traditional

K082079 - REGEN COLLAGEN SCAFFOLD (CS)
(FDA 510(k) Clearance)

K082079 · Regen Biologics, Inc. · Orthopedic
Dec 2008
Decision
148d
Days
Class 2
Risk

K082079 is an FDA 510(k) clearance for the REGEN COLLAGEN SCAFFOLD (CS), a Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen (Class II — Special Controls, product code OLC), submitted by Regen Biologics, Inc. (Hackensack, US). The FDA issued a Cleared decision on December 18, 2008, 148 days after receiving the submission on July 23, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K082079 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2008
Decision Date December 18, 2008
Days to Decision 148 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.