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Modulus System™
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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.
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