Ortho Development Gains Clearance for Knee Articulating Spacer Molds

Draper, Utah-based Ortho Development Corporation has been awarded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its KASM knee articulating spacer molds. KASM is a cement spacer mold intended for use in treating patients who develop an infection after undergoing total knee replacement surgery.

“KASM is a unique product that addresses a growing need in the total joint replacement market,” says Brent Bartholomew, president of Ortho Development. “We have used KASM with clinical success for the past several years in Japan and are excited to finally have FDA approval.”

With the increasing number of total knee arthroplasty (TKA) procedures performed in the United States the complication of TKA infection is also on the rise. The current approach in treating infection in TKA is a two-stage revision surgery involving removal of the original implants and temporarily packing the infected joint with antibiotic bone cement as either a static or articulating spacer. Static spacers force patients to keep their infected joint immobilized for 6-8 weeks until the infection is cured and the second-stage procedure is performed. KASM articulating spacers are designed to help preserve the range of motion, joint space, soft tissue tension, and allow for protected ambulation during that time.

KASM offers disposable femur and tibia molds designed for the creation of temporary articulating spacers. The molds form a smooth articulating condylar surface using antibiotic-laden bone cement. The molds come in various sizes, offer the ability for a surgeon to customize the spacer thickness based on patient anatomy, and can be overfilled to accommodate existing bony defects.

E. Marc Mariani, M.D. and Michael H. Bourne, M.D. from the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah assisted Ortho Development’s engineers with the development of KASM.

“The KASM spacer molds are a distinctive new option for the treatment of serious TKA infection,” said Bourne. “The combined benefit of elution of antibiotics and continued knee motion lead to improved patient comfort and activity both before and at the time of final knee implantation. We anticipate KASM will be invaluable in the treatment of difficult knee infection cases.”

Ortho Development makes devices for knee and hip joint reconstruction, spine treatment, and trauma.