WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / April 2026 / K254274

510(k) cleared

ARx® SAI Implant System

Life Spine, Inc. · Apr 16, 2026 · K254274

FDA cleared the ARx® SAI Implant System from Life Spine, Inc. on Apr 16, 2026 under K254274, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 30, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Life Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K261430 (TruLift Expandable System), K260571 (SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments), K260837 (VersaLift Expandable System), K253748 (Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System).

Questions & Answers

What did FDA clear under K254274?

K254274 is the FDA 510(k) for ARx® SAI Implant System, submitted by Life Spine, Inc.. FDA's decision date was Apr 16, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the ARx® SAI Implant System?

Life Spine, Inc., based in Huntley, IL, is the applicant of record for K254274.

How long did the K254274 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Apr 16, 2026, 107 days later.

← All decisions in April 2026