Collagen Meniscus Implant XL
510(k) K170364
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170364 | Date2 May 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Collagen Meniscus Implant XL is a resorbable bovine collagen scaffold designed for partial medial meniscal defects extending into the red-white zone. Classified as a scaffold under FDA product code OLC, it provides a biodegradable framework to support tissue regeneration and reinforce weakened meniscal tissue.
Supplied as a sterile, single-use device, the implant features a semi-lunar shape with a triangular cross-section. It is intended for surgical use in orthopedic procedures, with FDA clearance under 510(k) K170364, and is regulated under FDA regulation number 878.3300. Storage and handling must comply with sterile medical device protocols.
Other devices from Ivy Sports Medicine, LLC
Questions
AI-generated answers, 19 Sep 2026
What is the Collagen Meniscus Implant XL designed to address in a patient’s knee anatomy?
The Collagen Meniscus Implant XL is specifically designed for partial medial meniscal defects that extend into the red-white zone of the knee. This zone is critical for blood supply and tissue regeneration, making it a target area for scaffold-assisted repair to reinforce weakened meniscal tissue and support natural healing processes.
Is the Collagen Meniscus Implant XL reusable or intended for single-use, and how should it be stored?
The Collagen Meniscus Implant XL is supplied as a sterile, single-use device. To maintain sterility and integrity, it must be stored and handled according to standard sterile medical device protocols, ensuring it remains uncontaminated until use in surgical procedures.
What material is the implant made from, and how does it function in the body?
The implant is made from resorbable bovine collagen, which provides a biodegradable scaffold. This scaffold acts as a framework to support tissue regeneration and reinforce the meniscus by integrating with the patient’s natural tissue over time, gradually breaking down as the body replaces it with new, functional meniscal tissue.
What shape and cross-section does the Collagen Meniscus Implant XL have, and why is this important?
The implant features a semi-lunar shape with a triangular cross-section, designed to match the anatomical contours of the medial meniscus. This shape ensures proper fit and function within the knee joint, optimizing support for tissue regeneration and load distribution during movement.
How is the regulatory pathway for this device structured, and what does that mean for clinicians?
The Collagen Meniscus Implant XL received FDA clearance through a traditional 510(k) pathway (K170364), demonstrating substantial equivalence to a predicate device. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in partial medial meniscal defects extending into the red-white zone, providing clinicians with confidence in its regulatory standing.