MEKANIKA

The Spinal Stabilization Company

   

 

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Modulus System *

Fusion, Stabilization, or Augmentation?

Mekanika will offer the spine surgeon three procedural options using the Modulus System: Fusion, Stabilization and/or in combination to augment support of fusion, cages and artificial discs.

The modulus system is constructed of a proprietary carbon fiber composite architecture. Compliance is achieved by varying the composition. This unique composite, after static strength** and fatigue** testing, has shown to be superior to titanium in strength and fatigue resistance, resulting in longer life.

More importantly, Mekanika's FDA cleared biocompatible implant material has the same modulus of elasticity as bone itself, contributing to improved biomechanical compatibility and bone synthesis.

This compatibility may help reduce "transition/fusion disease" occurring in 25% of patients, as well as transferring force away from pedicle screws to help reduce the incidence of screw loosening.

Fusion

Modulus System is a State-of-the-Art fusion device composed of a proprietary carbon fiber composite** material that testing has confirmed is of exceptional strength and durability.

  • Tests show that the Modulus System load shares with the natural compressive loads on the disc while fusing the vertebral space.
  • In fatigue tests**, the Modulus System was subjected to 10 million cycles of a 50% failure load--without failure. And in a static flexion test**, it was 200% superior to currently available construct metals.
  • For utmost flexibility, the Modulus System may be used in a modular construct for single to multilevel fusions.
  • The Modulus System uses a manufacturing process** which allows for a stronger and lighter component which may be easier to implant.
  • The Modulus SYstem carbon fiber components show no artifact** on either MRI or CT scans.
  • The Modulus System is modular, with a multi-axial screw/plate interface.

Arthroplasty

The concept of joint stabilization without fusion is becoming increasingly accepted by the medical community. The Modulus System answers that need. The Modulus System is a revolutionary, load-sharing, internal spinal fixation system designed to provide stability to the spine of patients who are in need of stabilization--without permanent fusion and immobilization

  • Modulus System exhibits behavior similar to that of the intravertebral disc, with a loadshare of 35-65%** of the natural compressive loads on the disc.
  • Modulus System resists compressive**, tensile**, bending**, translational** and torsional** loads on the disc and joint.
  • Modulus System limits excess and abnormal motion in the joint. · Modulus System is manufactured** to have a similar modulus of elasticity as bone, wth a biomechanical compatibility that will reduce "transition/fusion disease."
  • In a pilot human cadaver study** measured with the SSG™ (Spinal Stiffness Gauge™), the Modulus System demonstrated the ability to carry approximately 50% of the normal compressive load on the intravertebral disc.
  • The Modulus System's curvilinear body is designed** and composed of materials that closely mimic the normal modulus of the spine.
  • The curvilinear body functions as a shock absorber to absorb the impact of excessive loads on the affected MSU.
  • The Modulus System is indicated for the 45%** of the patient population who exhibit loss of their original joint biomechanical stability, and are in need of an alternative treatment other than joint fusion.

Augmentation

Augmentation to fusion, interbody fusion devices, & artificial discs

The Modulus System implant is indicated to augment the support of fusion cages and artificial discs. When implanted in the joints adjacent to the fusion site, the Modulus System can significantly reduce the negative consequences of fusion.

The Modulus System is a long-term, reconstructive prosthesis, designed to support and restore function to the unstable MSU, while it restores normal motion between the vertebrae and the surrounding spine joints. The Modulus may replicate the function of the intravertebral disc and may support and distribute a percentage of the load normally carried by the spine during normal translation and rotation that augments the support provided by cages and artificial discs.


 

Mekanika, Inc. 1501 SE Decker Ave., Suite 107, Stuart, FL 34994
Phone 561-210-5671   Fax 561-892-8202