510(k) Clearance for eZspand™ Lateral Cage

Flowood, Mississippi-based Zavation Medical Products, LLC announced that the FDA granted 510(k) clearance for its eZspand™ Lateral Cage.

The eZspand Lateral Cage features, according to the company, “continual expansion” providing every patient with an “optimized fit” and “has up to 15° lordosis and the ability to back fill with bone graft.” With up to 6mm expansion of the implant from the insertion height produces “a large graft window that facilitates fusion.” The optimized fit “allows for enhancement of structural stability and improved sagittal balance.”

The eZspand Lateral Cage is an expandable lumbar interbody fusion device which is an addition to Zavation’s existing eZspand Interbody System.

According to the FDA, this type of intervertebral fusion device with bone graft, lumbar is “intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.” Specifically, Zavation eZspand Interbody System implants are, according to the company, “for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients” and may be used “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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.”

In terms of patients, the eZspand Interbody System is “intended to be used in patients who have had six months of non-operative treatment” and as “supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.”

Moreover, the eZspand Lateral Cage design offers efficiency because it “does not require secondary locking.” The procedural efficiency combined with the expansion ability makes the eZspand Lateral Cage a unique product offering.

In the press release, Zavation CEO Jeffrey Johnson said, “Our product development team’s dedication to creatively blending simplicity and precision in a robust product design has produced an expandable product that we believe is the new gold standard in facilitating patient fusion in a seamless and simplified procedure.”

Johnson continued, “With restoration of alignment being of critical importance, the eZspand™ Lateral was developed to help surgeons address stability and sagittal alignment, while maximizing lordotic correction. This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market leading customer service to best serve our surgeons and distributor network.”