Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
The Scaffold for Partial Medial Meniscal Defects, Resorbable Bovine Collagen (product code OLC) is a Class 2 implantable device regulated under 21 CFR 878.3300 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended for surgical repair and reinforcement of soft tissue injuries of the medial meniscus in patients with an intact meniscal rim and with defects extending at least into the red/white zone of the meniscus to ensure sufficient vascularization. The device is resorbable and replaced by the patient's own soft tissue; it is flagged as an implant but is not life-sustaining.
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Basic Information
- Product Code
- OLC
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242302 | RejuvaKnee Collagen Meniscus Implant | Oct 02, 2024 | Substantially Equivalent | Collagen Matrix, Inc. |
| K170364 | Collagen Meniscus Implant XL | May 02, 2017 | Substantially Equivalent | Ivy Sports Medicine, LLC |
| K082079 | REGEN COLLAGEN SCAFFOLD (CS) | Dec 18, 2008 | Substantially Equivalent | Regen Biologics, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.