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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 / January 2026 / K251558

510(k) cleared

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd. · Jan 12, 2026 · K251558

FDA cleared the Precision AI Surgical Planning System (PAI-SPS) from Precision AI Pty, Ltd. on Jan 12, 2026 under K251558, a traditional 510(k). The device falls under product code QHE, Shoulder Arthroplasty Implantation System, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 21, 2025. The decision came 236 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 Precision AI Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251558?

K251558 is the FDA 510(k) for Precision AI Surgical Planning System (PAI-SPS), submitted by Precision AI Pty, Ltd.. FDA's decision date was Jan 12, 2026, under product code QHE (Shoulder Arthroplasty Implantation System).

Who makes the Precision AI Surgical Planning System (PAI-SPS)?

Precision AI Pty, Ltd., based in Fortitude Valley, is the applicant of record for K251558.

How long did the K251558 review take?

FDA received the submission on May 21, 2025 and issued its decision on Jan 12, 2026, 236 days later.

← All decisions in January 2026