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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 / June 2026 / K260571

510(k) cleared

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

Life Spine, Inc. · Jun 2, 2026 · K260571

FDA cleared the SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments from Life Spine, Inc. on Jun 2, 2026 under K260571, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 19, 2026. The decision came 103 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), K260837 (VersaLift Expandable System), K254274 (ARx® SAI Implant System), K253748 (Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System).

Questions & Answers

What did FDA clear under K260571?

K260571 is the FDA 510(k) for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments, submitted by Life Spine, Inc.. FDA's decision date was Jun 2, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

Life Spine, Inc., based in Huntley, IL, is the applicant of record for K260571.

How long did the K260571 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Jun 2, 2026, 103 days later.

← All decisions in June 2026

Sources