DeviceClearance

Product code OLC— General, Plastic Surgery

Collagen Meniscus Implant XL

Classification name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OLC under 21 CFR 878.3300, via openFDA

Market context for product code OLC

FDA has cleared 3 devices under product code OLC between 2008 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OLC

Recent clearances under product code OLC

Data sourced from openFDA. This site is unofficial and independent of the FDA.