Kepler Two

The Interbody Device Component of the Kepler Spinal Fusion Systems with modular technology.

Kepler Two

Instrumentation


The Kepler Two Interbody Device System has intuitive instrumentation with intelligently designed features to provide effective control over the pre-sterilized implant in vivo.

Unique Features


The Kepler Two 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.

Treatment Areas


The Kepler Two Interbody devices are indicated for the use in treatment of: degenerative disc disease with accompanying radicular symptoms at one level from C2-T1. Degenerative disk disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Kepler Two implants are to be used with bone graft and implanted via an open, anterior approach. The Kepler Two Cervical Interbody is to be used with supplemental fixation.

Highlights Overview


Our systems intelligently address size variation requirements for use in patients with a wide variety of anatomical sizing requirements. The anatomical design of the Kepler Two interbody devices feature convex top ridged and lower sides to enhance stability and load sharing. This provides a zero-profile positioning that will allow for micromovement and the enactment of Wolff’s law for a strong and rapid fusion while maintaining position as intended.

Kepler Two cage has a 5° antero-posterior angulation, to restore healthy physiological lordosis to correct spine disorders, as well as facilitate and activate fusion, for long term stabilization of the cervical spine.

Kepler Two range is available in S(12x13mm), M(15x16mm), L(15x19mm) footprint variations with heights ranging from 5 to 10 mm.

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

Kepler Two

Benefits

  • Restores & maintains intervertebral distraction
  • Enhances bone regrowth with micro-movement for early fusion
  • Allows load sharing to activate fusion
  • Avoids complications of iliac crest graft
  • Ultrawide graft chamber for high-volume Rybone® or substitute graft packing to enhance fusion success rates.

Characteristics

  • The anatomical design of the Kepler Two interbody devices feature convex ridged top and lower sides to enhance stability and load sharing
  • Self-retaining for optimal implant stabilization
  • Dual Tantalum radio-opaque marker to provide accurate placement indication when used with radioscopic imaging
  • Unique modularity with interbody-to-plate fixation capabilities which may be useful in patients experiencing osteoporosis.

Range

  • Footprints: Small (12x13mm), Medium (15x16mm), Large (15x19mm)
  • 12 to 15 mm depth
  • 5 to 10mm distraction

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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