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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 / K261352

510(k) cleared

2D Hip Planning Software

One Ortho · Jun 8, 2026 · K261352

FDA cleared the 2D Hip Planning Software from One Ortho on Jun 8, 2026 under K261352, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 24, 2026. The decision came 45 days later, inside the 90 FDA-day goal for a 510(k).

One Ortho has one other decision in the tracker over the last 12 months: K253357 (b-ONE® Bipolar Head).

Questions & Answers

What did FDA clear under K261352?

K261352 is the FDA 510(k) for 2D Hip Planning Software, submitted by One Ortho. FDA's decision date was Jun 8, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the 2D Hip Planning Software?

One Ortho, based in Saint-Genis-Laval, is the applicant of record for K261352.

How long did the K261352 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Jun 8, 2026, 45 days later.

← All decisions in June 2026

Sources