ZERO-P is a stand-alone anterior cervical interbody fusion device designed to combine the functionality and benefits of a cervical interbody spacer and an anterior cervical plate.1-4
ZERO-P is designed to offer two key advantages over traditional anterior plating systems; Zero-P is designed to 1) reduce the risk of contacting local anatomical structures and 2) prevent contact with adjacent levels.5
ZERO-P features four rigid locking screws for fixation into adjacent vertebral bodies. The four rigid locking screws provide more rigid fixation in Flexion-Extension and Axial rotation than similar devices featuring two non-rigid screws (refer to graph).*
1 Kaiser, M.G., R.W. Haid Jr., B.R. Suback, et al. 2002. “Anterior cervical plating enhances arthrodesis after discectomy and fusion with cortical allograft”. Neurosurgery 50: 229-236.
2 Caspar, W.,F.H> Geisler, T. Pitzen, et a;. 1998. “Anterior Cervical plate stabilization in one and two level degenerative disease: overtreatment or benefit?” J. Spinal Disord. 11: 1-11.
3 Mobbs, R.J., P. Rao and N.K. Chandran. 2007. “Anterior cervical discectomy and fusion: analysis of surgical outcome with and without plating”. J. Clin. Neurosci. 14:639-642.
4 Moftakhar,R and G.R. Trost. 2004. “Anterior cervical plates: a historical perspective”. Neurosurg. Focus. 16:E8.
5 Park, J.B., Y.S. Cho and K.D. Riew. 2005. “Development of adjacent-level ossification in patients with an anterior cervical plate”. J. Bone Joint Surg. Am. 87:558-563.
*Data on file at DePuy Synthes, biomechanical test results may not be indicative of clinical performance
The DePuy Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of the spacer component of the DePuy Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
One of the risks of any surgical procedure is death. Other potential risks which may require additional surgery, include:
*These risks can also be associated with general risks of surgery.
Discard and DO NOT USE previously opened or damaged devices. Use only devices that are packaged in unopened and undamaged packages. DO NOT USE if there is a loss of sterility of the device. DO NOT USE past the expiration date.
The DePuy Synthes Zero-P cervical intervertebral body fusion devices are sterilized by gamma radiation. DO NOT RESTERILIZE. CONTENTS STERILE UNLESS INNER PACKAGE IS OPENED OR DAMAGED.
Components of Zero-P system should not be used in conjunction with components of, competing systems not manufactured by Synthes. In addition, mixing titanium or titanium alloy with stainless steel implant components is not recommended for metallurgical, mechanical and functional reasons.
Designed to reduce risk of contacting local anatomical structures.
Designed to prevent contact with adjacent levels.
May be used to facilitate surgeries where Zero-P is implanted adjacent to previous fusions
|Four rigid locking screws lock into plate at diverging angles||
Locked screws form bone wedge in vertebral bodies
Two screw fixation per level
Designed to provide similar biomechanics as a traditional 4 screw one-level plate and spacer construct (refer to graph)*
|Patented conical head locking screws||One-step screw locking|
|2 Footprints, 8 heights, 3 sagittal profiles||Multiple implant options designed to accommodate various patient anatomy|