By combining intuitive design with engineering excellence, the APEX Spine System sets a new standard in pedicle screw systems. The APEX Spine System was designed by industry leading spine surgeons and optimizes performance during surgery while providing intraoperative flexibility, allowing surgeons to effectively treat each complex spine and deformity patient’s unique needs.
The APEX Spine System is a comprehensive and versatile system of implants and instruments designed to safely and effectively treat patients with degenerative, complex and deformity pathologies. Comprehensive, Versatile, Optimized.
The APEX Spine System consists of longitudinal rods, pedicle screws (monoaxial, polyaxial and bolt-type), cannulated pedicle screws (monoaxial and polyaxial), hooks, lateral connectors and transverse (cross) connectors.
The APEX Spine System components are available in titanium alloy conforming to ASTM F136 specifications. Rods are also available in Cobalt Chromium alloy conforming to ASTM F1537 specifications.
Refer to the Surgical Technique Manual for additional information on how to use this device. Contact your Zimmer Spine Sales Representative for a copy of the current Surgical Technique.
The APEX Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system. Any condition not described in the Indications for Use. Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication.
Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section.
Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
LIMITED WARRANTY AND DISCLAIMER: APEX SPINE SYSTEM PRODUCTS ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED.