Spinal USA Introduces New Devices (Biloine Young @ OTW)
Spinal USA, headquartered in Pearl, Mississippi, introduced two of the firm’s new spinal treatment devices at the November meeting in Chicago of the North American Spine Society (NASS). The two technologies, which recently received FDA 510 (K) clearance, are the Vault Stand Alone ALIF System and the S-LOK PC Posterior Cervical System.
Company officials say that the VAULT Stand Alone ALIF System, designed for use with autogenous bone graft, is indicated for intervertebral body fusion of the spine in patients with degenerative disc disease with up to Grade I spondylolisthesis. It is intended for use at either a single level or at two contiguous levels between L2 and S1 in the lumbar spine. The System is designed to provide immediate mechanical fixation to adjacent vertebral bodies while maintaining a zero profile, and features a large graft window designed to maximize the opportunity for successful fusion.
The S-Lok PC Posterior Cervical System is intended, according to the October 28 press release, to promote fusion of the cervical and thoracic spine in skeletally mature patients and is indicated for use in the treatment of degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery and tumors. The system’s components include polyaxial screws with up to 40º of angulation for placement in the upper thoracic spine, and an array of lateral offsets, hooks, dominoes, transition rods and crosslinks designed to provide stabilization to promote fusion in the cervical/upper thoracic spine.
“These two technologies represent very important product line additions for Spinal USA,” said Rich Dickerson, Sr. VP Operations. “By providing a single product indicated for cases previously requiring up to two separate products, the VAULT System has the potential to reduce surgical trauma and yield a net cost savings. The S-Lok PC System is designed to offer surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility.” Spinal USA, LLC is a privately held company founded in 2005.