Cleared Special

Lumbar Spine Truss System - Plating Solution (LSTS-PS)

K253201 · 4Web, Inc. · Orthopedic
Feb 2026
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K253201 is an FDA 510(k) clearance for the Lumbar Spine Truss System - Plating Solution (LSTS-PS), a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on February 12, 2026, 139 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K253201 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date February 12, 2026
Days to Decision 139 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
aprevo? cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · Alphatec Spine, Inc. · Aug 2025
Resolve Anterior Cervical Plate System
K251436 · Pioneer Surgical Technology, Inc. · Jul 2025