FDA approves two Spinal USA spinal fusion products

1 November 2011 (Last Updated November 1st, 2011 18:30)

Spinal USA has received US Food and Drug Administration (FDA) 510(K) clearance for its new VAULT stand-alone ALIF system and S-Lok PC posterior cervical system.

Spinal USA has received US Food and Drug Administration (FDA) 510(K) clearance for its new VAULT stand-alone ALIF system and S-Lok PC posterior cervical system.

The VAULT stand-alone ALIF system is designed for intervertebral body fusion of the spine in patients with degenerative disc disease with up to grade I spondylolisthesis.

Spinal USA's system incorporates a large graft window to maximise the opportunity of immediate mechanical fixation to adjacent vertebral bodies while maintaining a zero profile.

The S-Lok posterior cervical system will enhance fusion of the cervical and thoracic spine in skeletally mature patients. It is used to treat degenerative disc disease, spondylolisthesis, spinal stenosis, fracture / dislocation, revision of previous cervical spine surgery and tumours.

The posterior cervical system features polyaxial screws with up to 40º of angulation for placement in the upper thoracic spine (T1-T3), and an array of lateral offsets, hooks, dominoes, transition rods and crosslinks to enhance fusion in the cervical / upper thoracic spine (C1-T3).

Spinal USA senior vice-president Rich Dickerson said that the VAULT system would reduce surgical trauma while improving cost savings.

He added that the S-Lok PC system would provide surgeons a comprehensive fixation system with greater intraoperative flexibility.