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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253201

510(k) cleared

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

4Web, Inc. · Feb 12, 2026 · K253201

FDA cleared the Lumbar Spine Truss System - Plating Solution (LSTS-PS) from 4Web, Inc. on Feb 12, 2026 under K253201, a special 510(k). The device falls under product code KWQ, Appliance, Fixation, Spinal Intervertebral Body, regulated at 21 CFR 888.3060 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

4Web, Inc. has 2 other decisions in the tracker over the last 12 months: K252834 (Sacroiliac Joint Truss System (SJTS)), K253200 (Cervical Spine Truss System - Stand Alone (CSTS-SA)).

Questions & Answers

What did FDA clear under K253201?

K253201 is the FDA 510(k) for Lumbar Spine Truss System - Plating Solution (LSTS-PS), submitted by 4Web, Inc.. FDA's decision date was Feb 12, 2026, under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Who makes the Lumbar Spine Truss System - Plating Solution (LSTS-PS)?

4Web, Inc., based in Frisco, TX, is the applicant of record for K253201.

How long did the K253201 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Feb 12, 2026, 139 days later.

← All decisions in February 2026

Sources