CDSCO UID IMP/MD/2019/000240_5048078f7606720801b3644d65c07cf5_897d435025bb16537c9fac55f4299c0c

Non-Cervical Spinal Spacer

Zimmer India Private Limited·Device Class Class C·India CDSCO·Brand: Polaris 5.5 spinal system - Connector

Registration details

UID: IMP/MD/2019/000240_5048078f7606720801b3644d65c07cf5_897d435025bb16537c9fac55f4299c0c
Device class: Class C
Brand name: Polaris 5.5 spinal system - Connector
License holder: Zimmer India Private Limited
Approving authority: CDSCO
Product information: The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (Polaris 5.5 spinal system - Connector) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (Polaris 5.5 spinal system - Connector) with up to Grade 1 spondylolisthesis at the involved level(Polaris 5.5 spinal system - Connector). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery