Vendor/Manufacturer: Aesculap® Implant Systems, Inc.
Product/Product Line: Modulift Vertebral Body Replacement (VBR) System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3060
FDA Regulation Description Classification Name:
Spinal Intervertebral Body Fixation Orthosis
FDA Classification Product Code: PLR
FDA Classification Product Code Device Name:
Spinal Vertebral Body Replacement Device - Cervical
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation.
Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.
Indications for Use:
The Modulift VBR System is indicated for use in the cervical spine (C3-C7 vertebral bodies for the small VBR implant) and thoracolumbar spine (T1-L5 vertebral bodies for the small/medium/large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Modulift VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Modulift VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The Modulift VBR System is intended to be used with supplemental fixation systems that have been cleared by the FDA. When used in the thoracolumbar spine, the Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. When used in the Cervical Spine at one or two levels, the Modulift Vertebral Body Replacement (VBR) System is intended to be used with supplemental fixation systems (i.e., ABC Anterior Cervical System or the Quintex Cervical System). When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA (i.e., Aesculap S4 Cervical System).
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