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 Regen Biologics, Inc., Ivy Sports Medicine, LLC and Collagen Matrix, Inc..
3
Total
3
Cleared
97d
Avg days
2008
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen Devices (Product Code OLC)
3 devices
Cleared
Oct 02, 2024
RejuvaKnee™ Collagen Meniscus Implant
Collagen Matrix, Inc.
Orthopedic
58d
Cleared
May 02, 2017
Collagen Meniscus Implant XL
Ivy Sports Medicine, LLC
Orthopedic
85d
Cleared
Dec 18, 2008
REGEN COLLAGEN SCAFFOLD (CS)
Regen Biologics, Inc.
Orthopedic
148d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.