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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 / July 2026 / K262251

510(k) cleared

ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)

Globus Medical, Inc. · Jul 31, 2026 · K262251

FDA cleared the ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) from Globus Medical, Inc. on Jul 31, 2026 under K262251, a special 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 1, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Globus Medical, Inc. has 7 other decisions in the tracker over the last 12 months: K254043 (TRIVANCE Hip Stem), K253739 (SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System), K253401 (SCRIPT Implant System), K261043 (AUTOBAHN Nailing System).

Questions & Answers

What did FDA clear under K262251?

K262251 is the FDA 510(k) for ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert), submitted by Globus Medical, Inc.. FDA's decision date was Jul 31, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K262251.

How long did the K262251 review take?

FDA received the submission on Jul 1, 2026 and issued its decision on Jul 31, 2026, 30 days later.

← All decisions in July 2026