WARSAW — Ignite Orthopedics LLC, a privately held product development and commercialization organization located in the “Orthopedic Capital of the World,” Warsaw, Indiana, announced that it has received FDA clearance to market its Radial Head Arthroplasty System. This marks the first FDA clearance for the company and represents a significant milestone in the company’s mission to create a complete shoulder and elbow arthroplasty portfolio.

The Radial Head Arthroplasty System is intended to treat patients who have experienced fracture or degenerative arthritis of the proximal radius. Radial head fractures have been reported in the Journal of Shoulder and Elbow Surgery as one of the most common elbow fractures, representing approximately one-third of all elbow fractures.

Russ Parrott, vice president of research and development at Ignite said, “The radial head arthroplasty market is often underserved and there are several clearly reported clinical issues in the literature with existing systems such as implant loosening, overstuffing and dissociation. Orthopedic surgeons who perform these procedures are in need of new solutions that simplify the most difficult aspects of the surgical procedure and provide more reliable outcomes, which is what this system was designed to address.”

Matt Purdy, co-founder of Ignite noted, “Surgeons have responded very favorably to the Radial Head Arthroplasty System trials. The system allows for in-situ addition of a spacer when more height is needed for joint stability; a unique patent-pending feature. The spacer is inserted into place without the need to exchange heads or dislocate the radius and remove the trial which can be quite challenging, disruptive to the surrounding soft tissue and can add time to the case.”

Anand Murthi, MD, chief of shoulder and elbow surgery at MedStar Union Memorial Hospital/MedStar Orthopaedic Institute added, “For me, one of the many exciting aspects of the Radial Head Arthroplasty System is that the trials and spacers are radiolucent, allowing me to clearly assess the spacing of the entire elbow joint to ensure proper size selection. Nearly all trials on the market are radiopaque and block a portion of the joint line during fluoroscopy, which can lead to over-tensioning of the joint. Additionally, the ‘Ready-Set Go™’ kit contains all implant sizes and sterile single-use instrumentation in one compact box, which is an upgrade for our surgical staff and adds value in the evolving healthcare landscape.”

“We are thrilled to partner with this elite team of surgeons to make a difference in the shoulder and elbow space. By collaborating with American Shoulder and Elbow Surgeon members, Neer Award winners, and Resident and Fellowship Directors, we have valuable insight from subject matter experts who publish on a wide variety of shoulder and elbow topics. These surgeons practice in numerous clinical settings, such as ambulatory surgery centers, outpatient clinics, and academic and private institutions. These partnerships ensure our portfolio will deliver disruptive solutions that solve real clinical and economic problems,” remarked Brian Hodorek, co-founder of Ignite.