Ortho Development has received the US Food and Drug Administration (FDA) clearance for its patented KASM knee articulating spacer molds, designed for use in treating patients who develop an infection after undergoing total knee replacement surgery.
The cement spacer molds are designed to help preserve the range of motion, joint space, soft tissue tension, and allow for protected ambulation during that time.
The KASM spacer molds offer new option for the treatment of serious total knee arthroplasty (TKA) infection.
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.
Ortho Development president Brent Bartholomew said KASM is a unique product that addresses a growing need in the total joint replacement market.
"We have used KASM with clinical success for the past several years in Japan and are excited to finally have FDA approval," Bartholomew added.
The disposable femur and tibia molds offered by KASM allow 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.
Ortho Development currently markets its products through a network of independent sales reps and distributors in the US and through Japan Medical Dynamic Marketing (Japan MDM) in Japan.