Renovis Surgical’s lumbar fusion systems gain FDA clearance
Renovis Surgical Technologies has gained clearance from the US Food and Drug Administration (FDA) for the commercialisation of its posterior lumbar Tesera porous titanium interbody fusion systems.
The Tesera fusion systems portfolio includes implants for posterior (PLIF) or transforaminal (TLIF) approaches in straight as well as curved options.
Developed using additive manufacturing (three-dimensional printing) and the firm’s porous structure called Tesera Trabecular Technology, the systems come in different heights, widths and lengths to address various patient anatomies.
Tesera Trabecular Technology enables attachment of the bone to implant surfaces and is intended to allow biologic fixation deep into the pore structure to ensure long-term stability and strength.
The technology is made from titanium alloy and supports bone in-growth, while it matches the modulus of elasticity of cancellous bone.
With an average pore diameter of approximately 500μm, the technology is designed to allow the necessary vascularisation for sustaining living bone.
In preclinical studies, the Tesera Trabecular Technology bone plugs demonstrated new bone formation and bone remodelling in and adjacent to the porous structure without implant-associated adverse effects on the host bone.
Founded in 2009, Renovis Surgical makes implants for application in orthopaedics, spine, and trauma.
In addition to the posterior lumbar systems, the FDA previously cleared the firm’s Tesera SA anterior spinal fusion system in 2013, Tesera acetabular total hip reconstruction system in 2014, first-generation Tesera posterior lumbar interbody range in 2015, and Tesera SC anterior cervical fusion system last year.
Image: Tesera Interbody family. Photo: courtesy of PRNewsfoto/Renovis Surgical Technologies.