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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 / February 2026 / K260222

510(k) cleared

Mako Total Knee Application

Mako Surgical Corp. · Feb 25, 2026 · K260222

FDA cleared the Mako Total Knee Application from Mako Surgical Corp. on Feb 25, 2026 under K260222, a special 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 Jan 26, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mako Surgical Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260222?

K260222 is the FDA 510(k) for Mako Total Knee Application, submitted by Mako Surgical Corp.. FDA's decision date was Feb 25, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Mako Total Knee Application?

Mako Surgical Corp., based in Weston, FL, is the applicant of record for K260222.

How long did the K260222 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Feb 25, 2026, 30 days later.

← All decisions in February 2026