THINK Surgical Receives FDA 510(k) Clearance for Medacta GMK Sphere^® and SpheriKA^® implants on TMINI^® Miniature Robotic System

(FREMONT, CA) Aug 29th, 2024 – THINK Surgical, Inc., an innovator Miniature Robotic System has
received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with
the GMK^® Sphere and SpheriKA^® Knee Systems from Medacta International under a
Collaboration Agreement between the two companies.
The GMK Sphere and SpheriKA Knee Systems have been added to THINK Surgical’s ID-
HUB™, a proprietary data bank of implant modules for use with the open platform version
of its TMINI System.
THINK Surgical is committed to providing orthopedic surgical robots that support implants
from multiple manufacturers. The addition of the GMK Sphere implant, a leading ball-in-
socket knee design, and the SpheriKA implant, the world’s first knee system specifically
designed based on the principles of Kinematic Alignment, to THINK Surgical’s ID HUB
database will allow Medacta customers access to robotic assisted technology for total knee
replacement in the United States.
“I am pleased to announce our collaboration with THINK Surgical in the US Market,” stated
Matt Goudy, managing director and president of Medacta USA. “This partnership marks
another step forward in our commitment to offering cutting-edge technologies that drive
sustainable innovation forward and enhance our ability to deliver personalized solutions
for surgeons and patients worldwide.”
“Medacta’s commitment to innovation aligns well with THINK Surgical’s dedication to
innovation in robotics.” said Stuart Simpson, president, and chief executive officer of THINK
Surgical. “We are excited to partner with Medacta in the USA to offer customers greater
choice in patient treatment options.”
About THINK Surgical, Inc.
THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and
markets orthopedic robots.
THINK Surgical actively collaborates with healthcare professionals to refine our orthopedic
products, improving the lives of those suffering from advanced joint disease with precise,
accurate, and intelligent technology.  Please refer to the instructions for use for the TMINI
Miniature Robotic System for a complete list of indications, contraindications, warnings,
and precautions. For additional product information, please
visit www.thinksurgical.com.

THINK Surgical and TMINI are trademarks of THINK Surgical, Inc.
About Medacta

Medacta is an international company specializing in the design, production, and
distribution of innovative orthopedic products, as well as in the development of
accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in
joint replacement, spine surgery, and sports medicine. Medacta is committed to improving
the care and well-being of patients and maintains a strong focus on healthcare
sustainability. Medacta’s innovation, forged by close collaboration with surgeon experts
globally, began with minimally invasive surgical techniques and has evolved into
personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports
surgeons with a comprehensive and tailored program dedicated to the advancement of
medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and
operates in over 50 countries.

For additional product information, please visit
www.medacta.us.com
GMK Sphere and SpheriKA are trademarks of Medacta International, SA

Media Contacts:
THINK Surgical – Nick Margree
nmargree@thinksurgical.com
Medacta – Gianluca Olgiati
media@medacta.ch