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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 / September 2025 / K251780

510(k) cleared

iGPS Navigation Instruments

SI-BONE, Inc. · Sep 15, 2025 · K251780

FDA cleared the iGPS Navigation Instruments from SI-BONE, Inc. on Sep 15, 2025 under K251780, 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 Jun 10, 2025. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SI-BONE, Inc. has 2 other decisions in the tracker over the last 12 months: K253488 (iFuse INTRA Ti Implant System), K253094 (iFuse Bedrock Granite Implant System).

Questions & Answers

What did FDA clear under K251780?

K251780 is the FDA 510(k) for iGPS Navigation Instruments, submitted by SI-BONE, Inc.. FDA's decision date was Sep 15, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the iGPS Navigation Instruments?

SI-BONE, Inc., based in Santa Clara, CA, is the applicant of record for K251780.

How long did the K251780 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Sep 15, 2025, 97 days later.

← All decisions in September 2025

Sources