# K212527: Cervical Spine Truss System Plating Solution (CSTS-PS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: May 17, 2022 after 279 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K841189 (1984). 434 ancestors in all.
No later device cites it as a predicate yet.
0 of 435 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131025: Archon Anterior Cervical Plate System, Nuvasive, Inc. (2013) Summary page 6.
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS), 4Web, Inc. (2021) Summary page 6.
- K173159: Cervical Spinal Truss System (CSTS) Interbody Fusion Device, 4Web, Inc. (2018) Summary page 6.
- K190870: Cervical Spinal Truss System-Stand Alone (CSTS-SA), 4Web, Inc. (2019) Summary page 6.

## Indications for use
The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K212527
Methodology: https://510kreport.com/methodology