FREMONT,
Calif., July 23, 2024 /PRNewswire/ -- THINK
Surgical, Inc., an innovator in the field of orthopedic surgical
robots, today announced that its TMINI® Miniature
Robotic System (TMINI 1.1) has received 510(k) clearance from the
U.S. Food and Drug Administration (FDA).
THINK Surgical Receives FDA 510(k)
Clearance for TMINI Miniature Robotic System (TMINI 1.1)
The TMINI 1.1 system software provides substantial new
capabilities empowering surgeon choice throughout total knee
arthroplasty procedures. The new TMINI PRO™
workflow, enables Positional Refinement and Optimization of the
implant tailored to the patient's needs. The workflow's dynamic
data capture and real-time feedback allows surgeons to make
positional adjustments to help fine-tune implant positioning and
stability. The TMINI PRO workflow is intuitive and customizable
around surgeon preferences and implant philosophy choices. Surgical
plan adjustments are wirelessly transmitted to the TMINI Robot for
a seamless surgical experience.
"The new TMINI PRO workflow enabled by the updated TMINI 1.1
software provides me with everything I need from robotics for my
total knee replacements," said Dr. Alexander Sah, Co-Director of the Institute of
Joint Restoration. "The added ability to assess real-time soft
tissue balance intraoperatively and to adjust my plan according to
my preferences in the OR helps me deliver the best possible
outcomes for my patients."
The TMINI System includes a wireless robotic handpiece that
assists surgeons in performing total knee
replacement. Following a CT based three-dimensional surgical
plan which may be updated following intraoperative joint
assessment, the TMINI robotic handpiece automatically compensates
for surgeon hand movement to locate bone pins along precisely
defined planes. Cutting guides are then connected to the bone pins
for accurate bone resection. TMINI is easy to use and replaces many
of the instruments currently used for manual knee replacement
surgery.
"This software release is a major enhancement to our TMINI
Robotic System that not only meets our customers' needs but is a
differentiator for our platform in this industry," said
Stuart Simpson, President, and Chief
Executive Officer of THINK Surgical. "It is a major accomplishment
for our company to receive a 2nd FDA clearance for our TMINI System
in less than 15-months. This demonstrates our development
capabilities and commitment to innovation as a focused robotics and
digital surgery company."
THINK Surgical is committed to maximizing customer access to its
handheld TMINI Miniature Robotic System, including two distinct
customer segments, one that prefers an open platform where the
customer can choose from a range of implants on the robot and
another that prefers an exclusive platform where the customer gains
access to the robot in return for loyalty to a single implant
brand. THINK Surgical intends to continue adding new implant
options to its open implant library over time. The choice of
exclusive platform or open implant platform, combined with the
robust feature offering and ease of use of the TMINI system should
appeal to a broad customer base who may have been resistant to
robotics until now.
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, TMINI and TMINI Pro are trademarks of THINK
Surgical, Inc.
Media Contact:
THINK Surgical Inc.
Nick Margree
nmargree@thinksurgical.com
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SOURCE THINK Surgical, Inc.