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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 / K261002

510(k) cleared

Pectus Blu System

Biomet Microfixation · Jun 2, 2026 · K261002

FDA cleared the Pectus Blu System from Biomet Microfixation on Jun 2, 2026 under K261002, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 26, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Biomet Microfixation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261002?

K261002 is the FDA 510(k) for Pectus Blu System, submitted by Biomet Microfixation. FDA's decision date was Jun 2, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Pectus Blu System?

Biomet Microfixation, based in Jacksonville, FL, is the applicant of record for K261002.

How long did the K261002 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Jun 2, 2026, 68 days later.

← All decisions in June 2026