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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 / May 2026 / K260077

510(k) cleared

OrthoGrid Hip AI® 4.0

OrthoGrid Systems, Inc. · May 29, 2026 · K260077

FDA cleared the OrthoGrid Hip AI® 4.0 from OrthoGrid Systems, Inc. on May 29, 2026 under K260077, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 12, 2026. The decision came 137 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for OrthoGrid Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260077?

K260077 is the FDA 510(k) for OrthoGrid Hip AI® 4.0, submitted by OrthoGrid Systems, Inc.. FDA's decision date was May 29, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the OrthoGrid Hip AI® 4.0?

OrthoGrid Systems, Inc., based in Midvale, UT, is the applicant of record for K260077.

How long did the K260077 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on May 29, 2026, 137 days later.

← All decisions in May 2026