Pedical screw spinal systems are an implant system fit to the patient's anatomical and physiological requirements. The pedical screw spinal assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. The devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Each pedical screw system must be in compliance with mechanical testing requirements.
Applicable Testing Standards
- ASTM F1691 - Axial Pull-Out Strength Medical Bone Screws Test Equipment
- ASTM F1717 Spinal Implant Static and Fatigue Test Equipment
- ASTM F1798 Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM F2706 Fatigue Static Spinal Implants Test Equipment
Recommended Test Machine
Static and fatigue forces up to 50 kN (11,250 lbf)
Frequency ratings up to 75 Hz
Oil-free, all electric actuator for clean test conditions
Lower purchase, operating, and maintenance costs than hydraulic equivalents
