# K242302: RejuvaKnee™ Collagen Meniscus Implant

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Oct 2, 2024 after 58 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: 10 generations back to K921895 (1992). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170364: Collagen Meniscus Implant XL, Ivy Sports Medicine, LLC (2017) Summary page 5.

## Indications for use
RejuvaKnee 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 RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient’s own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.

Source page: https://510kreport.com/device/K242302
Methodology: https://510kreport.com/methodology