# K201769: Cavetto [MAX] Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Sep 3, 2020 after 66 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K003155 (2001). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172320: Neurostructures Cavetto® Cervical Cage System, Neurostructures, Inc. (2018) Summary page 4.
- K142041: Porosteon Phusion Metal Cervical Cage, Porosteon, Inc. (2014) Summary page 5.

## Indications for use
The Cavetto® [MAX] Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® [MAX] Cervical Cage System is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K201769
Methodology: https://510kreport.com/methodology