February 2019

FDA Approves Knee Implant IDE, Clears Bio-Integrative Bone Fixation Implant

The US Food & Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for Swedish-based Episurf Medical’s Episealer personalized knee implant and has granted 510(k) (premarket submission) clearance to Israeli-based OSSIO Ltd.’s bio-integrative material indicated “for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (eg, rigid fixation implants, cast, brace).”

Episealer: The IDE approval for Episealer will allow the company to begin a clinical study and is the first step toward a Premarket Approval (PMA) application. According to Episurf Medical, the 180-patient prospective, randomized, controlled, multi-center (Europe and US) study will evaluate the safety and effectiveness of the implant 2 years after implant. The study’s control is microfracture for the treatment of focal femoral knee chondral or osteochondral lesions. The implants and surgical drill guides “are developed for treating localized cartilage injury in joints,” the company stated, adding that its system “enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention.”

OSSIO Pin Product Family: According to FDA documents, the cleared OSSIO Pin Product Family “is a fixation device made of degradable poly (L-lactide-co-D, Llactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body [so no permanent hardware is left behind]. The mineral fibers are made from materials that are incorporated into bone.” While the platform will have broad application across all of orthopedics, the first commercial use will be in the foot and ankle for the treatment of forefoot conditions where hardware removal surgeries are prevalent, according to company statements. The company said the mechanical strength of the novel implant is initially significantly higher than cortical bone, and its performance supports bone regeneration throughout the healing process. It then gradually transfers load to the native bone following the rehabilitation phase.

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