Cuptimize Announces 510(k) FDA Clearance of its New Proprietary Software
BELLEAIR BLUFFS, Fla., March 9, 2020 -- Cuptimize Inc., a medical device software company, focused on spinopelvic motion abnormalities, announced today that it has received FDA clearance for their latest software. The system provides a preoperative and intraoperative solution that relies exclusively on x-ray and requires no CT scan for the preoperative analysis module.
The Cuptimize solution allows hip surgeons to understand when the patient has a problem, determine cup placement to mitigate risk and have clear indications of when to use dual mobility implants. The system also integrates directly with intraoperative navigation solutions.
"We know that total hip replacement is an excellent operation,” said Jonathan M. Vigdorchik, MD, “but certain patients can be at increased risk of complications. Understanding the hip-spine relationship allows for truly personalizing a hip replacement surgery to ensure all patients have an excellent outcome. This is a paradigm shift in the way we perform the operation, and the single biggest change in hip replacement surgery in the last 40 years."
In simple terms, Cuptimize answers two fundamental questions: Is there a problem with pelvic tilt? If so, how do I solve it?
"Every hip surgeon knows that spinopelvic motion is a problem, but the solutions have been so complicated and impractical that few of us have even tried. Dual mobility implants have been used to bridge the knowledge gap because we really just didn't know which patients had a problem and which did not. Overnight, with the 510(k) clearance, the Cuptimize system has changed the playing field. Now, I immediately know which patients have a problem and which don't and the indications for dual mobility have become much more clear. This is a big win for hip surgeons and their patients." said Charles DeCook, MD
The Cuptimize software is a revolution in spinopelvic tilt analysis that is now available to all orthopedic surgeons in the United States.
"With Cuptimize,” said Dr. Andrew J. Cooper, MD, “Surgeons can preoperatively plan their patient's specific cup position simply with x-rays. In the operating room, the fully integrated solution allows the cup to be seen, not as a singular position, but as a range from sitting to standing. This should bring confidence to surgeons of all approaches when implanting their acetabular component."
About Cuptimize Inc.
Cuptimize Inc is dedicated to software enabled medical devices, focusing on creating a revolutionary solution for spinopelvic tilt analysis. The company provides a preoperative and intraoperative solution that relies exclusively on x-ray. This solution should be scalable to the orthopedic community based on its simplicity and how it can be it be integrated into surgeons' current practices.