Spinal Elements gets FDA clearance for Ventana A anterior lumbar fusion system

Spinal Elements, a US company focusing on products and technologies for spine surgery procedures, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Ventana A Anterior Lumbar Interbody Fusion (ALIF) System.

The company has completed its first clinical cases using the device, and has introduced the system through a limited market launch.

Ventana A is a 3D printed titanium interbody implant designed to restore segmental alignment and stability in lumbar fusion procedures. The device features the hinged architecture common to the Ventana platform, intended to maximize bone graft volume and containment during implantation.

Its design aims to minimize titanium density, optimize load sharing to reduce subsidence risk, and improve intraoperative visualization. The system adds an ALIF-specific offering to the existing Ventana product series, which already spans lumbar and cervical fusion applications.

“ALIF is a powerful procedure and a workhorse for many spine surgeons, which is why we set out to develop a best-in-class system that maximizes its clinical benefits,” stated Ron Lloyd, CEO of Spinal Elements. “Building on the proven Ventana platform, this contemporary system increases Spinal Elements’ portfolio offering and procedural reach to a greater number of surgeons and distribution partners. 

“Combined with intuitive instrumentation and efficient packaging, Ventana A is designed to enhance clinical performance and operating room efficiency, demonstrating our commitment to continued innovation – working with surgeon partners to develop systems that are meaningfully differentiated and deliver improved outcomes.”

First clinical use

The first case was performed by Dr. A.J. Rush III at Texas Spine Consultants in Addison, Texas. “The Ventana A system delivers a clinical advantage to everyday challenges for spine surgeons,” commented Dr. Rush. “The large graft window allows for maximal graft delivery as well as improved visualization for fusion assessment and distributes load across the entire surface to reduce subsidence risk. 

“Having used the instrumentation in both lab and clinical settings, I can attest to Ventana A’s ability to offer a best-in-class ALIF solution.”

Dr. Rory Mayer, a neurosurgeon practicing at Texas Spine & Scoliosis in Austin, Texas, also used the system. “It has everything needed to maximize fusion potential for my patients: porous 3D printed titanium interbody, a large opening to facilitate bone graft placement, and a hinged lid to contain the bone graft and prevent graft from migrating from the interbody device during insertion into the disc space,” he said.

Earlier this year Nivalon Medical launched a fully patient-specific, motion-preserving spinal implant built entirely without metal.