Medical Creations Inc., doing business as Xtremity, has released an innovative thermoformable socket system that can be heated, custom vacuum formed, trimmed and assembled in an hour.
During follow-up appointments, the prosthetist can use a heat gun to make fitting adjustments—improving comfort, convenience and mobility for persons with transtibial limb loss or limb difference.
Founded in 2017, Medical Creations Inc. is an investor-owned prosthetics company based in Denver. Maynard Carkhuff, a highly respected executive with more than 30 years’ experience in the prosthetics industry, joined Xtremity as President and CEO in 2021. Carkhuff previously held the same position at Flex-Foot Inc. (acquired by Össur) and Freedom Innovations (acquired by Ottobock). Carkhuff was instrumental in helping the company secure additional investor funding and guided efforts to commercialize the XtremityTT Socket System. The company’s board chairman is Bob Kerrey, former Governor and Senator for the state of Nebraska. Kerrey is a recipient of the Congressional Medal of Honor for heroism in combat and has worn transtibial sockets and prosthetic devices for more than 50 years.
The XtremityTT Socket System replicates the durability and functionality of carbon fiber laminated sockets while achieving the benefits of adjustable sockets. More than $20 million was invested in product development and testing.
“The commercialization of the XtremityTT Socket System is a major milestone. We look forward to introducing our technology to the O&P community at the AOPA National Assembly in September,” said Carkhuff. “We are entering the market with socket technology that embraces changes to the patient’s residual limb and changes in our industry.”
XtremityTT is a complete system with components manufactured to precise tolerances and the highest quality ISO standards. The foundation for the system is a socket “Preform” that is injection molded using a proprietary carbon reinforced polymer (a material the O&P industry has never experienced). There is no layup or lamination, and no employee exposure to hazardous raw materials, vapors, or carbon dust. XtremityTT has interchangeable suspension systems (pin lock, suction, and vacuum) and a unique mechanism incorporated into the base plate that enables fine-tuning of alignment. Every component is injection molded, CNC milled, or 3D printed in Colorado.
“We’ve created socket technology that supports faster, easier, safer, and more environmentally sustainable socket fabrication. Our goal is to help the prosthetist make life easier for patients when they need a new socket. The XtremityTT socket also makes it more cost efficient for the clinic, and less burdensome for the patient, when there are future fitting and discomfort issues,” said Chief Clinical Officer Gary Berke, MS, CP, FAAOP. “By making spot adjustments over a period of weeks, months, or even years, the prosthetist can keep the patient comfortable and active until a replacement socket is needed.”
While there are no existing standards or requirements for socket testing, the XtremityTT was load tested (3 million cycles, heel and toe) adhering to ISO standards for prosthetic devices. A 38-patient controlled study involving seven clinics, as well as a battery of tests for ultimate strength, torsion, pressure mapping, and material creep, were completed prior to the product’s release. Patient “testers” included extreme athletes who logged more than 30 million steps.
“We encourage prosthetists to embrace our thermoformable socket technology that will create a more comfortable, convenient, and expeditious experience for transtibial patients,” said Carkhuff.
Additional information is available on the company’s website at xtremity.com.
