SYNTHES VERTEBRAL SPACER TI

K020152MQP4/16/2002

Applicant

SYNTHES (USA)

Intended Use

The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Ti Spacer System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone.

Indications for Use

The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone. The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Predicate Devices

  • K003275 - Synthes SynMesh System (MQP)