FDA Product Code OLC: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen
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.
Leading manufacturers include Collagen Matrix, Inc..
FDA 510(k) Cleared Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen Devices (Product Code OLC)
About Product Code OLC - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OLC since 2008, with 3 receiving FDA clearance (average review time: 97 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OLC have taken an average of 58 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.
OLC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →