Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
OLC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300
Classification
FDA Product Code
OLC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.3300
Review panel
OR
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.