Kepler One

The Cervical Plating and Fixation Component of the Kepler Spinal Fusion Systems with true low profile design.

Kepler One

Instrumentation


The Kepler One Cervical Plating and Fixation System has intuitive instrumentation with intelligently designed features to provide effective control over the pre-sterilized products.

Unique Features


The Kepler One System’s unique modularity may provide subsequent stability or fixation which may be useful in patients experiencing osteoporosis. Additionally, it’s dynamic distal and central screw combination for plate fixation provides stabilization for the fusion site and effectively stresses the graft for rapid bone reformation while ensuring secure positioning throughout the entire fusion process.

The true low profile plating mechanism has a finished height of 1.8mm and a built-in screw lock feature.

Treatment Areas


The Kepler Cervical Plate System is intended for Anterior Screw Fixation at the vertebral bodies of the cervical spine (C2-C7). The Kepler Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Highlights Overview


The Kepler One devices feature an anterior cervical plating and fixation system with an integrated screw-locking design for 1 to 4 level cervical fusion. Our systems intelligently address size variation requirements for use in patients with a wide variety of anatomical sizing requirements having anterior plate sizes up to 93mm in length and 4.0 to 4.5mm diameter screws up to 20mm in length.

Kepler One provides distal fixation into the Superior and Inferior vertebral bodies and central cervical fixation with locking dynamic screws through intermediate vertebral bodies in treatments of up to 4 levels; to enhance load sharing and activate fusion for long term stabilization of the cervical spine and unique modularity also allows for interbody fixation to the cervical plate.

The Kepler One plating system is a true 1.8mm low profile form factor with total screw insertion into the design integrated screw auto-locking mechanism which provides restricted backout for fixation efficacy and leaves the Kepler One plate smooth for optimal comfort for your patient.

Streamlined and Comprehensive instrumentation delivers adaptable solutions to address individual surgeon requirements.

Kepler One

Kepler One


Benefits

  • Dynamic post-operatively to increase the load on the graft and therefore increase the rate of fusion.
  • Semi constraint rotational concept which allows for rotation at the plate/screw interface.
  • Ultralow profile for patient comfort to prevent post-op dysphagia/dysphonia
  • Built-in screw locking (no added screw locking mechanism for easy set)
  • Multi-level fixation with modular features allowing for Interbody fixation capabilities.
  • Titanium

Characteristics

  • Integrated screw locking design
  • 1 to 4 level fixation
  • Precise placement for distal, central and interbody screws
  • Polyaxial Screws
  • Plate Modularity for additional fixation

Range

  • Plates up to 93mm in length
  • Intended for 1 to 4 level cervical fixation
  • Screw length from 12 to 20mm
  • Screw Ø 4.0 and 4.5mm diameter rescue

Additional Information


Pre-sterilized implants with peel-off labels for UDI compliant trackability. Implants remain sterile for 5 years as indicated on the packaging provided.

Prior to opening, operating room personnel may ready the clearly indicated product codes from the box cover label.

Spinal implantable medical devices class II / class I Instruments, manufacturer Orbbo Surgical. Please read the IFU and the surgical technique.

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