Interbody Spacer is available in two lengths (27mm and 32mm), two lordotic angles (0 and 6 degrees) and in heights from 7mm to 18mm in one millimeter increments. The device is curved (kidney shaped) to match the anatomical shape of the anterior spine with an endplate sparing design to resist subsidence. The spacer has a tapered leading edge to aid in insertion of the implant, and allows the implant to be self-distracting. 

Description

The Zyston Straight Spacer System was designed to restore height and lordotic angle in the spine. The Zyston Straight Spacer System is available in two styles (lordotic and convex), in a variety of lengths, widths and heights to optimize fit. The convex style is elliptical in shape to match the natural contours of the endplates with an endplate sparing design to resist subsidence. The lordotic style is tapered to aid in the restoration of lordosis in the anterior-posterior plane with an endplate sparing design to resist subsidence. The top and bottom walls of the implant body have serrated teeth to provide stability by engaging the endplates to help resist shear and rotational forces. Curved superior and inferior surfaces provide structural integrity. The central area allows for placement of autograft material allowing for subsequent bone growth through the interior of the device. When used for vertebral body replacement, bone graft material may be used. The PEEK-OPTIMA™ LT1 material (PEEK-OPTIMA is a trademark of Invibio Limited) is radiolucent and permits unobstructed radiographic assessment of the fusion mass. However, due to its radiolucency, the Zyston Straight device has tantalum markers within the body of the spacer to help visualize implant orientation within the spine during surgery and post-operatively. A threaded insertion feature is machined into the PEEK body to allow use of an inserter.

The Zyston Curve Interbody Spacer System is intended to be inserted into the intervertebral disc space for intervertebral body fusion. The Zyston Curve Interbody Spacer is designed to restore height and lordotic angle in the spine. The Zyston Curve

Interbody Spacer is available in two lengths (27mm and 32mm), two lordotic angles (0 and 6 degrees) and in heights from 7mm to 18mm in one millimeter increments. The device is curved (kidney shaped) to match the anatomical shape of the anterior spine with an endplate sparing design to resist subsidence. The spacer has a tapered leading edge to aid in insertion of the implant, and allows the implant to be self-distracting. The spacer has teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity allows for placement of autograft material allowing for subsequent bone growth through the interior of the device. The Zyston Curve Spacer is a lumbar spacer with an internal articulating feature to facilitate implant placement. The design incorporates a threaded titanium insert which has the potential to pivot within the body of the spacer. When connected to the inserter, the insert allows the implant to pivot relative to the shaft, enabling the user to guide the implant into the desired position within the intervertebral space. The PEEK -OPTIMA™(a trademark of Invibio Limited) material is radiolucent and permits unobstructed radiographic assessment of the fusion mass. However, due to its radiolucency, the Zyston Curve device has tantalum markers within the body of the spacer to help visualize implant orientation within the spine during surgery and post-operatively.

Indications

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

The Zyston Curve Interbody Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Zyston Curve Interbody Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Zyston Curve Interbody Spacer System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Contraindications

Contraindications include, but are not limited to:

• Infection, systemic, spinal or localized
• Morbid obesity
• Signs of local inflammation
• Fever or leukocytosis
• Metal sensitivity/allergies to the implant materials
• Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
• Grossly distorted anatomy due to congenital abnormalities
• Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or the quality of the bone graft)
• Any case not needing a bone graft and fusion or where fracture healing is not required
• Any case requiring the mixing of metals from different components
• Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition
• Any case not described in the indications
• Any patient unwilling to cooperate with the postoperative instructions
• Any time implant utilization would interfere with anatomical structures or expected physiological performance.
• Prior fusion at the level(s) to be treated.