Cleared Traditional

RejuvaKnee? Collagen Meniscus Implant

K242302 · Collagen Matrix, Inc. · Orthopedic
Oct 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K242302 is an FDA 510(k) clearance for the RejuvaKnee? Collagen Meniscus Implant, a Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen (Class II — Special Controls, product code OLC), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on October 2, 2024, 58 days after receiving the submission on August 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K242302 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date October 02, 2024
Days to Decision 58 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.