BoneSupport Gets De Novo Clearance for Its Cerament G Bone Void Filler

BoneSupport has received the FDA’s De Novo clearance for its Cerament G gentamicin-eluting ceramic bone void filler.

The agency describes the new device type as a “resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial.”

The product is indicated for use in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the surgical treatment of osteomyelitis in the extremities.

By eluting gentamicin, the FDA says, Cerament G can reduce the recurrence of chronic osteomyelitis and protect bone healing. It can also augment temporary hardware to help support bone fragments during the surgical procedure. But it is not intended to provide structural support during the healing process. The product resorbs and is replaced by bone during the healing process.

Sweden-based BoneSupport estimates that 50,000 patients are treated each year in the U.S. for bone infections and the market is growing by up to 7 percent a year.