SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE

K031914MQP7/12/2003

Applicant

SPINAL CONCEPTS, INC.

Intended Use

Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Indications for Use

Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Predicate Devices

  • K010530 - Interpore Cross GEO™ Structure (MQP)
  • K020048 - Interpore Cross GEO™ Structure (MQP)
  • K001340 - DePuy AcroMed Stackable Cage™ System (MQP)