Category: Minimally Invasive Surgery (MIS)
The VIPER® F2 Transfacet Pedicular System is a transfacet pedicular screw intended to stabilize the spine as an aid to fusion that is inserted using a minimally invasive approach across the facet joint to gain purchase in the pedicle.
To surgeons that treat adult degenerative patients with alternative fixation devices through an MIS approach, the VIPER F2 System provides time efficiency and stability through a less invasive approach, because of:
The VIPER F2 System provides surgeons with direct fixation of mobile anatomy with less disruption of muscles and tissue than alternative methods.
1Cunningham BW, Serhan, H.A Biomechanical Analysis of the VIPER® F2 Facet Fixation System Augment Interbody Spinal Arthrodesis: An in vitro Human Cadaveric Model
2NOTE: Results of cadaveric model testing may not correlate to clinical performance.
The VIPER F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Disease conditions which have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
Absence of posterior spinal elements including the pedicle, pars interarticularis, facet joints, spinous process and the majority of the lamina are contraindications to implantation.
Any entity or conditions that totally preclude the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia, are relative contraindications. Other relative contraindications include obesity, certain degenerative diseases, or foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
PRECAUTION: The implantation of facet screws should be performed only by experienced spinal surgeons with specific training in the use of this screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
WARNING: This product has labeling limitations. See package insert for additional warnings, precautions and possible adverse effects.
CAUTION: USA law restricts this device to sale by or on the order of physician.
|Transfacet screw with a pedicle screw design||
Stable construct to aid in fusion
|Designed to be used in MIS procedures||
Allows a single incision providing streamlined approach
Decreased risk of infection with fewer procedural steps
Decreased operating room time
Preservation of muscle and tissue
|Two-piece polyaxial implant design||
Allows for implant modularity
Provides ability to customize the implant to meet patient specific anatomy