# K253201: Lumbar Spine Truss System - Plating Solution (LSTS-PS)

- Pathway: 510(k) (Special)
- Applicant: 4Web, Inc.
- Decided: Feb 12, 2026 after 139 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: 11 generations back to K990745 (1999). 133 ancestors in all.
No later device cites it as a predicate yet.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS), 4Web, Inc. (2021) Summary page 5.

## Indications for use
The Lumbar Spine Truss System Plating Solution (LSTS-PS) non-integrated plate 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, anterolateral, or anterior 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 integrated plate may be attached and remain attached to a Lateral Spine Truss System (LSTS) Interbody Fusion Device or an Anterior Spine Truss System (ASTS) 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 integrated plate is intended to be used with supplemental fixation (e.g. posterior fixation).

Source page: https://510kreport.com/device/K253201
Methodology: https://510kreport.com/methodology