Orthopedic surgical robotics maker THINK Surgical has announced that its TMINI Miniature Robotic System (TMINI 1.1) has received 510(k) clearance from the US Food and Drug Administration (FDA).
The system enables minimally invasive orthopedic procedures with enhanced precision and outcomes.
The TMINI Miniature Robotic System is a robotic-assisted system designed to aid surgeons in performing complex orthopedic surgeries with greater accuracy and control. This system is specifically engineered for minimally invasive procedures, allowing for smaller incisions, reduced tissue damage and faster recovery times for patients.
In a press release, THINK Surgical explained that the TMINI 1.1 system software offers significant new capabilities empowering surgeon choice throughout total knee arthroplasty procedures.
This includes the TMINI PRO workflow, which allows for positional refinement and optimization of the implant customized to a patient’s needs. The workflow’s dynamic data capture and real-time feedback provide surgeons with enhanced control through intuitive interfaces. This enables surgeons to perform delicate maneuvers and make fine-tuned positional adjustments to help refine implant positioning and stability with confidence, reducing the likelihood of errors.
Surgical plan adjustments are wirelessly transmitted to the TMINI Robot for a seamless surgical experience.
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The TMINI System features a wireless robotic handpiece designed to assist surgeons in performing total knee replacements. Using a CT-based three-dimensional surgical plan, which can be updated based on intraoperative joint assessments, the TMINI robotic handpiece automatically adjusts for surgeon hand movements to accurately position bone pins along precisely defined planes. Cutting guides are then attached to these bone pins to ensure precise bone resection.
TMINI is user-friendly and replaces many of the instruments currently used in manual knee replacement surgery, said THINK.
Other key features of TMINI 1.1 include a compact, miniaturized design that allows it to be used in tighter surgical spaces, making it ideal for minimally invasive procedures. Its small footprint also means it can be easily integrated into existing operating rooms without requiring significant modifications.
Patients undergoing procedures with the TMINI system can expect smaller incisions, less postoperative pain, reduced scarring and faster recovery times compared to traditional open surgeries. These advantages contribute to improved overall patient outcomes and satisfaction.
Related: First-of-Its-Kind Robotic Surgery Assistant by Zimmer Biomet for Enhanced Shoulder Procedures
“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 CEO of THINK Surgical.
“It is a major accomplishment for our company to receive a second 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,” noted Simpson.
According to Grand View Research, the global surgical robots market size was valued at approximately $3.92 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 9.5 percent from 2024 to 2030.
The agency cites the global shortage of physicians and surgeons and increasing adoption of automated instruments for surgery as major factors driving market growth. Additionally, the growing incidence of bone degenerative diseases and rising number of hip and knee replacement surgeries due to increasing cases of arthritis and osteoporosis are also expected to drive growth.
According to the Agency for Healthcare Research and Quality report, over 450,000 hip replacement surgeries are performed every year in the US.
Current surgical robotics market leaders Intuitive Surgical and Stryker hold over 75 percent of the market value, according to GlobalData.
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