# K190870: Cervical Spinal Truss System-Stand Alone (CSTS-SA)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Aug 12, 2019 after 131 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: 23 generations back to K841189 (1984). 301 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 312 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173159: Cervical Spinal Truss System (CSTS) Interbody Fusion Device, 4Web, Inc. (2018) Summary page 5.
- K132029: Vault-C Intervertebral Body Fusion Device, Spinal USA (2013) Summary page 5.
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 5.

## Most influential descendants
- K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (2023), 3 descendants of its own
- K231739: Cervical Spine Truss System (CSTS) (2023), 2 descendants of its own
- K193153: SPIRA-C Integrated Fixation System (2020), 2 descendants of its own
- K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA) (2024), 1 descendant of its own
- K253894: BMD Titanium Spinal Fusion System (2026), 0 descendants of its own

## Indications for use
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices.

Source page: https://510kreport.com/device/K190870
Methodology: https://510kreport.com/methodology