Zyston® Straight & Curve Interbody Systems

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.

Warnings

The surgeon should be aware of the following:

• The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant. The size and shape of the human spine presents limiting restrictions of the size and strength of implants. No implant can be expected to withstand the unsupported stresses of full weight bearing.
• The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. The device must be handled and stored carefully, protected from damage, including from corrosive environments. They should be carefully unpacked and inspected for damage prior to use.
• All instruments must be cleaned and sterilized prior to surgery.
• As with all orthopaedic implants, the Zyston Straight Spacer System and the Zyston Curve Interbody Spacer System should never be reused under any circumstances.
• Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
• Postoperative care is important. The patient should be instructed in the limitations of his/her implant and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing.
• The Zyston Straight Spacer System and Zyston Curve Interbody Spacer System have not been evaluated for safety and compatibility in the MR environment. The Zyston Straight Spacer System and Zyston Curve Interbody System have not been tested for heating or migration in the MR environment.
• Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.
• Biomet Spine implants should not be used with implants or instruments from another manufacturer for reasons of metallurgy, mechanics and design.
• Based upon dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, and any other factor which may impact on the performance of the device.

Precautions

Preoperative:

• Only patients that meet the criteria described in the indications should be selected.
• Patient conditions and/or pre-dispositions such as those addressed in the Contraindications Section should be avoided.
• Care should be used in the handling and storage of the implant components. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments.
• All instruments should be cleaned and sterilized before use.

Intraoperative:

• Any instruction manuals should be carefully followed.
• At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in a loss of neurological functions.

Postoperative:

• The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.
• Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the components are complications which can occur as a result of excessive or early weight-bearing or excessive muscular activity. The risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
• To allow maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process.
• If a nonunion develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue these stresses can cause eventual bending, loosening, or breakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by radiographic examination. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.
• Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants / devices that have been even momentarily placed in or used on a different patient.

Possible adverse effects include, but are not limited to:

• Bending, loosening or fracture of the implants or instruments
• Loss of fixation
• Sensitivity to a metallic foreign body, including possible tumor formation
• Skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications
• Nonunion or delayed union
• Infection
• Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis and cerebral spinal fluid leakage
• Gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency and/or loss of consortium
• Pain or discomfort
• Bone loss due to resorption or stress shielding, or bone fracture at, above or below the level or surgery (fracture of the vertebra)
• Hemorrhage of blood vessels and/or hematomas
• Misalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height
• Bursitis
• Bone graft donor site pain
• Inability to resume activities of normal daily living
• Reoperation
• Death

USA: 720-894-9016

To submit a complaint, please email SpineComplaints@highridgemedical.com

10225 Westmoor Dr. Westminster, CO 80021 USA

To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 720-894-9016.

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA