# K200115: Cavetto-SA Cervical Cage System

- Pathway: 510(k) (Special)
- Applicant: Neurostructures, Inc.
- Decided: Sep 24, 2020 after 247 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 16 generations back to K003155 (2001). 144 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173077: Cavetto-SA Cervical Cage System, Neurostructures, Inc. (2018) Summary page 5.

## Most influential descendants
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K223190: Hive™ Standalone Cervical System (2022), 5 descendants of its own
- K240838: Spectrum Spine Cervical Cage System (2024), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own

## Indications for use
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

Source page: https://510kreport.com/device/K200115
Methodology: https://510kreport.com/methodology