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About this product

Division: Spine
Category: Cervical

ZERO-P® Spacer 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

Unlike traditional anterior plating systems, the ZERO-P Spacer does not extend beyond the confines of the intervertebral disc space. The plate is designed to both minimize contact with local anatomical structures and to prevent contact with adjacent levels.5

ZERO-P Spacer features four rigid locking screws for fixation into adjacent vertebral bodies. In biomechanical testing, the four rigid screws provided more rigid fixation in flexion-extension and axial rotation than similar devices featuring two non-rigid screws.*

Disclaimers/ Footnotes:
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.

* The ZERO-P Spacer was compared to ZERO-P VA Spacer and VECTRA™ Cervical Plating System in a static cadaveric range of motion study, Biomechanical Study: Zero-profile anterior cervical interbody fusion devices. Bench test results may not necessarily be indicative of clinical performance.

ZERO-P Stand-alone Spacer ZERO-P Stand-alone Spacer cage front ZERO-P Stand-alone Spacer cage side
 

Indications for Use

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.

 

CONTRAINDICATIONS

  1. Use of the DePuy Synthes Zero-P is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
  2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
  3. Severe obesity or degenerative diseases are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
  4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions. These patients may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.
  5. Prior fusion at the level to be treated.
  6. Any condition not described in the Indications for Use.

WARNINGS

One of the risks of any surgical procedure is death. Other potential risks which may require additional surgery, include:

  • device component fracture
  • loss of fixation
  • pseudoarthrosis (i.e., non-union)
  • fracture of the vertebrae*
  • neurological injury*
  • vascular or visceral injury*

*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.

Features & Benefits

  Features Benefits
ZERO-P Stand-alone Spacer bone wedge Zero profile
  • Designed to minimize contact with local anatomical structures.

 

  • Designed to prevent contact with adjacent levels

 

  • May be used to facilitate surgeries where ZERO-P® Spacer is implanted adjacent to previous fusions
ZERO-P Stand-alone Spacer rendering 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)*
ZERO-P Stand-alone Spacer graph Patented conical head locking screws
  • One-step screw locking
ZERO-P Stand-alone Spacer x-ray 2 Footprints, 8 heights, 3 sagittal profiles
  • Multiple implant options designed to accommodate various patient anatomy

 

Footnotes:
* The ZERO-P Spacer was compared to ZERO-P VA Spacer and VECTRA™ Cervical Plating System in a static cadaveric range of motion study, Biomechanical Study: Zero-profile anterior cervical interbody fusion devices. Bench test results may not necessarily be indicative of clinical performance.

DSUS/SPN/0616/1355 07/2016

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.
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