# K170364: Collagen Meniscus Implant XL

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Sports Medicine, LLC
- Decided: May 2, 2017 after 85 days
- Product code: OLC (Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921895 (1992). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082079: Regen Collagen Scaffold (CS), Regen Biologics, Inc. (2008) Summary page 5.

## Most influential descendants
- K242302: RejuvaKnee™ Collagen Meniscus Implant (2024), 0 descendants of its own

## Indications for use
The Ivy Sports Medicine Collagen Meniscus Implant (CMI) is intended for use in surgical procedures for the reinforcement and repair 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 for the CMI must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CMI reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CMI is not a prosthetic device and is not intended to replace normal body structure.

Source page: https://510kreport.com/device/K170364
Methodology: https://510kreport.com/methodology