FDA grants Orthofix 510(k) clearance for Forza PTC interbody spacer system

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Orthofix International has received US Food and Drug Administration 510(k) clearance, and announced the US limited market launch of the Forza PTC (PEEK titanium composite) spacer system.

Designed and manufactured using a proprietary method, Forza PTC spacers combine PEEK and 3D-printed titanium end plates into a porous interbody device for lumbar spine fusion procedures. Forza PTC interbody spacers are designed to restore normal disc height in patients suffering from degenerative disc disease.

“The Forza PTC spacing systems offer a unique porous technology that allows patient bone ingrowth into the surface of the implant as well as bone growth through the center of the device,” says Scott Stanley, an orthopaedic surgeon and co-developer of the device. “Additionally, the PEEK core allows for clear imaging so physicians can assess the patient’s fusion maturation post-operatively to determine if enough healing has occurred for return to regular activities.”

The Forza PTC spacer system is the latest in a range of PEEK titanium composite (PTC) interbody spacer products sold by Orthofix.

The titanium endplates of Forza PTC are manufactured by 3D printing to specific pore size, interconnectivity and porosity requirements. The device is designed with interconnected 400 micron diameter pores intended to promote potential bone ingrowth.

The Forza PTC spacer system is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.