# K172320: Neurostructures Cavetto® Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Feb 26, 2018 after 209 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: 14 generations back to K003155 (2001). 88 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 5.
- K150765: LDR Spine ROI-C Cervical Cage System, Ldr Spine USA (2015) Summary page 5.
- K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S, Ldr Spine USA, Inc. (2012) Summary page 5.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 5.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 5.

## Most influential descendants
- K230607: SPICCA Cervical Fusion Cages (2023), 0 descendants of its own
- K201769: Cavetto [MAX] Cervical Cage System (2020), 0 descendants of its own
- K181590: Neurostructures Cavetto® [MAX] Cervical Cage System (2018), 0 descendants of its own

## Indications for use
The Neurostructures Cavetto® 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 Neurostructures Cavetto® 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 Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K172320
Methodology: https://510kreport.com/methodology