Medical Device Manufacturer · US , Weston , FL

Mako Surgical Corp. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 2005

Total

Cleared

Denied

Mako Surgical Corp., is a medical device manufacturer based in Weston, US. Now part of Stryker, the brand continues to operate under the parent company with a focus on robotic-assisted surgical systems.

The company maintains a strong FDA 510(k) regulatory record with 33 FDA 510(k) clearances from 33 total submissions. Orthopedic devices represent 88% of its submission portfolio. Mako's clearance history spans from 2005 to 2026, demonstrating sustained innovation in joint reconstruction and orthopedic surgery applications.

Recent cleared devices include total knee and hip applications, as well as shoulder and multi-compartmental knee systems. The company's portfolio reflects specialization in robotic-assisted platforms for orthopedic surgical procedures. Latest clearance activity in 2026 confirms continued regulatory engagement and product development.

Explore the complete list of device names, product codes, and individual clearance dates in the database.

510(k) submissions have been managed by Mako Surgical Corp. as regulatory consultant.

FDA 510(k) Regulatory Record - Mako Surgical Corp.

33 devices

1-12 of 33