The U.S. Food & Drug Administration (FDA) has granted 510(k) clearance to a lumbar intervertebral body fusion system.
According to the FDA 510(k) summary document, the system is indicated for “intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.”
The system is also intended for “use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.”
The device is called the LumiVy™ NanoVy™ Ti Lumbar IBF System. According to the manufacturer (VySpine, LLC) the system is available in a variety of sizes, heights, and lordotic angles. Its breadth of offerings means it can be used for “nearly any lumbar interbody approach.”
In order to qualify for 510(k) clearance, the device must be substantially equivalent to a predicate device, which, in this case, was the LumiVy Lumbar IBF System. It is also substantially equivalent to the secondary predicate device, the SeaSpine NanoMetalene Spacer System.
The LumiVy NanoVy Ti Lumbar IBF System utilizes VySpine’s NanoVy Ti coating technology which is a “nano coating of CP Titanium onto an implant surface, such as a PEEK polymer.” NanoVy Ti “improves the performance of the native polymer making for a superior implant.”.
The technology comes from a partnership between VySpine and Implant Surfaces LLC.
According to VySpine, the NanoVy Ti coating is “engineered to facilitate direct osteoblast attachment to the entire surface of the LumiVy implant.”
The coating has been demonstrated to “increase expulsion resistance of the LumiVy implant.” The coating does this “without compromising the radiolucency, or favorable modulus of elasticity, of the PEEK material.”
VySpine, LLC is based in Tallahassee, Florida, and offers a broad portfolio of spinal products. This latest clearance only expands its already diverse product line of lumbar solutions. In addition to the LumiVy NanoVy Ti Lumbar IBF System, VySpine has other interbody solutions as well as posterior fixation solutions, corpectomy solutions, and supplemental fixation devices.
Implant Surfaces LLC is a medical device company based in Longmont, Colorado, that provides surface solutions for a variety of device and instrument applications. The company develops nano-engineered coatings and surface treatments for spinal and orthopedic applications.
