Medical Device Manufacturer · US , Fremont , CA

THINK Surgical, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2015

Total

Cleared

Denied

THINK Surgical, Inc. is an innovator in orthopedic surgical robotics based in Fremont, California. The company develops miniature robotic systems that assist surgeons in performing joint replacement procedures.

THINK Surgical has received 22 FDA 510(k) clearances from 22 total submissions since 2015. Orthopedic devices represent 86% of the company's regulatory portfolio. The company remains active, with its latest clearance in 2026.

The company's core offering is the TMINI® Miniature Robotic System, a wireless robotic platform designed for total knee replacement. THINK Surgical has developed proprietary technologies including TPLAN, a software platform for three-dimensional surgical planning, and ID-HUB, a data bank enabling surgeons to select from multiple implant partners. This approach differentiates the company by prioritizing implant choice within a single robotic operating system.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by THINK Surgical, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - THINK Surgical, Inc.

22 devices

1-12 of 22