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Zimmer, Inc.

Nex-Link® Spinal Fixation System

Confidently address cervicothoracic fusion with strength, speed and versatility.

The strength of the Nex-Link construct is derived from the sum of its parts. Commercially pure titanium rods facilitate easier contouring while improving the construct’s strength. Equally impressive is the Nex-Link polyaxial screw that offers a 65º range of motion (ROM) or 6.1mm of offset to minimize the effort needed to capture the rod.

Independent lab results have demonstrated a four-fold improvement in axial grip testing and a two-fold improvement in flexion-extension resistance over baseline competitors. This provides piece of mind when transitioning over one the most biomechanically and anatomically challenging areas of the spine—the cervicothoracic junction. Nex-Link’s strength and versatility allows for transitioning to thoracolumbar fixation systems. Its CT Junction system facilitates quicker procedures and sturdy transitions for longer constructs.

Indications

n intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Nex-Link Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The polyaxial screws are not intended to be placed in the cervical spine. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. The physician and the patient, taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure, must make any decision to remove the device.

Contraindications

  • Presence of overt infection and/or localized inflammation
  • Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis
  • Suspected or documented metal allergy or intolerance
  • Any patient having inadequate tissue coverage over the operative site
  • Any time implant utilization would interfere with anatomical structures or expedite physiological performance, such as impinging on vital structures
  • Severe comminuted fractures such that segments may not be maintained in satisfactory proximate reduction
  • Use in displaced, nonreduced fractures with bone loss
  • The presence of marked bone absorption or severe metabolic bone disease that could compromise fixation
  • Medical or surgical condition, that would preclude the potential benefit of surgery, such as elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), fever, leukocytosis or marked left shift in the WBC differential count
  • The physical contact of Nex-Link implants with metal implants made of anything other than implant grade titanium, such as stainless steel (ASTM F138 or MP35N), or other dissimilar metals
  • Absence or compromise of significant stabilizing elements
    Presence of any neural or vascular deficits or other compromising pathology, which may be further injured by device intervention
Use in Children

use of posterior spinal instrumentation in children has been reported in the literature. Preferably, children should be older than 10 to receive this implant but need not have reached skeletal maturity. In special circumstances, implants may be used at younger ages.