RejuvaKnee™ Collagen Meniscus Implant

FDA 510(k) K242302 · Collagen Matrix, Inc.

Substantially Equivalent

510(k) numberK242302

Submission

Device name
RejuvaKnee™ Collagen Meniscus Implant
Applicant
Collagen Matrix, Inc.
Oakland, NJ, US
Received
August 5, 2024
Decision date
October 2, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLC – Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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…

Other 510(k)s with product code OLC

510(k)DeviceApplicantDecision
K170364Collagen Meniscus Implant XLOLC · Traditional Ivy Sports Medicine, LLC05/02/2017SE
K082079Regen Collagen Scaffold (CS)OLC · Traditional Regen Biologics, Inc.12/18/2008SE

More from Regen Biologics, Inc.

510(k)DeviceDecision
K251191Collagen Dura Regeneration Membrane - RepairGXQ · Traditional 11/18/2025SE
K243071Bovine Dermis Collagen Dermal MatrixKGN · Traditional 12/19/2024SE
K233203Soft Tissue Augmentation Resorbable MatrixNPL · Traditional 05/01/2024SE
K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMQV · Traditional 03/12/2024SE
K231942Mineral Collagen Composite Bioactive Extra MoldableMQV · Special 08/02/2023SE
K221735Mineral Collagen Composite Bioactive MoldableMQV · Traditional 12/20/2022SE
K213341Fibrillar Collagen Wound DressingKGN · Traditional 05/31/2022SE
K202183Porcine Mineral Collagen CompositeNPM · Traditional 04/02/2021SE
K201859Porcine Mineral Collagen Composite MoldableNPM · Traditional 09/11/2020SE
K182074Mineral Collagen Composite Bioactive MoldableMQV · Traditional 03/21/2019SE

Questions and answers

When was RejuvaKnee™ Collagen Meniscus Implant cleared by the FDA?

RejuvaKnee™ Collagen Meniscus Implant (K242302) received a 510(k) decision of Substantially Equivalent on October 2, 2024, 58 days after the submission was received.

What is the product code of K242302?

The FDA product code is OLC – Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen, a Class II (moderate risk) device regulated under 21 CFR 878.3300.