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GII pedicle fixation

The GII pedicle fixation system is designed for the thoracolumbar and sacral spine with different longitudinal elements according to the specific needs of each patient. The Titanium pedicle screws used as anchors are orthogonal or poliaxial. The longitudinal elements are Titanium rods, ostaPek® plates or Titanium plates. Multiple connectors and extenders are available to complement the pedicle fixation system.

Clinically used in Europe since 1994 (eVos system) and 2007 (flexStaas system). Cleared by the FDA under codes MNH, KWP and MNI since 1998 – 510(k) K98082, K032604, K051089 and K083567.

The GII pedicle fixation is patented, has been developed in the USA and is manufactured in Switzerland.

The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment, (2) Fracture, (3) Dislocation, (4) Scoliosis, (5) Kyphosis, (6) Spinal tumor, and/or (7) Failed previous fusion (pseudoarthrosis). The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non- cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative spondylolisthesis with objective evi- dence of neurologic impairment, (2) Fracture, (3) Dislocation, (4) Scoliosis, (5) Kyphosis, (7) Spinal tumor, and/or (8) Failed previous fusion (pseudoarthrosis).

The GII pedicle screws are available in diameter from 4.75 mm to 8.5 mm and different length from 30 mm to 80 mm. The GII pedicle rods and plates are available in various lengths. The GII pedicle plates come both sloted and half-sloted.

For complete details on the use of the GII pedicle fixation system refer to the valid Information for Use.

Peer-reviewed clinical publications on the GII pedicle fixation system.