# K253200: Cervical Spine Truss System - Stand Alone (CSTS-SA)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: Dec 11, 2025 after 76 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: 25 generations back to K841189 (1984). 433 ancestors in all.
No later device cites it as a predicate yet.
0 of 434 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device, 4Web Medical, Inc. (2023) Summary page 6.
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS), 4Web, Inc. (2021) Summary page 6.
- K231739: Cervical Spine Truss System (CSTS), 4Web Medical, Inc. (2023) Summary page 6.

## Indications for use
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is 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 or fixation anchors 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. When using the CSTS-SA interbody with fixation anchors, the device must be used with supplemental fixation.

Source page: https://510kreport.com/device/K253200
Methodology: https://510kreport.com/methodology