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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 / January 2026 / K252834

510(k) cleared

Sacroiliac Joint Truss System (SJTS)

4Web Medical · Jan 28, 2026 · K252834

FDA cleared the Sacroiliac Joint Truss System (SJTS) from 4Web Medical on Jan 28, 2026 under K252834, a traditional 510(k). The device falls under product code OUR, Sacroiliac Joint Fixation, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 5, 2025. The decision came 145 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

4Web Medical has 2 other decisions in the tracker over the last 12 months: K253201 (Lumbar Spine Truss System - Plating Solution (LSTS-PS)), K253200 (Cervical Spine Truss System - Stand Alone (CSTS-SA)).

Questions & Answers

What did FDA clear under K252834?

K252834 is the FDA 510(k) for Sacroiliac Joint Truss System (SJTS), submitted by 4Web Medical. FDA's decision date was Jan 28, 2026, under product code OUR (Sacroiliac Joint Fixation).

Who makes the Sacroiliac Joint Truss System (SJTS)?

4Web Medical, based in Frisco, TX, is the applicant of record for K252834.

How long did the K252834 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Jan 28, 2026, 145 days later.

← All decisions in January 2026

Sources