Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3300](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3300) → OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

# OLC · Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

_General, Plastic Surgery · 21 CFR 878.3300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC

## Overview

- **Product Code:** OLC
- **Device Name:** Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
- **Regulation:** [21 CFR 878.3300](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3300)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K242302](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC/K242302.md) | RejuvaKnee™ Collagen Meniscus Implant | Collagen Matrix, Inc. | Oct 2, 2024 | SESE |
| [K170364](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC/K170364.md) | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | May 2, 2017 | SESE |
| [K082079](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC/K082079.md) | REGEN COLLAGEN SCAFFOLD (CS) | Regen Biologics, Inc. | Dec 18, 2008 | SESE |

## Top Applicants

- Collagen Matrix, Inc. — 1 clearance
- Ivy Sports Medicine, LLC — 1 clearance
- Regen Biologics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/OLC)

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