# K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Mar 10, 2021 after 152 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: 10 generations back to K990745 (1999). 132 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190016: Lateral Plate System, Corelink, LLC (2019) 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
- K233966: Anterior Spine Truss System-Stand Alone (ASTS-SA) (2024), 1 descendant of its own
- K253201: Lumbar Spine Truss System - Plating Solution (LSTS-PS) (2026), 0 descendants of its own
- K253200: Cervical Spine Truss System - Stand Alone (CSTS-SA) (2025), 0 descendants of its own

## Indications for use
The Lumbar Spine Truss System Plating Solution (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The LSTS-PS with integrated fixation is intended to be attached and remain attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).

Source page: https://510kreport.com/device/K203065
Methodology: https://510kreport.com/methodology