OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen Class II

FDA Device Classification

Classification Details

Product Code
OLC
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
OR
Medical Specialty
General, Plastic Surgery
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242302collagen matrixRejuvaKnee™ Collagen Meniscus ImplantOctober 2, 2024
K170364ivy sports medicineCollagen Meniscus Implant XLMay 2, 2017
K082079regen biologicsREGEN COLLAGEN SCAFFOLD (CS)December 18, 2008