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 polyaxial. 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, K083567 and K210306.
The GII pedicle fixation is patented, has been developed in the USA and is manufactured in Switzerland.
The Coligne GII Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft. The GII Spinal Fixation System is intended for use for one or more of the following: (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma.
The system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The GII orthogonal pedicle screws are available in diameter from 4.75 mm to 8.5 mm and different length from 30 mm to 80 mm.
The flexStaas pedicle screws are available as polyaxial or monoaxial screws in diameter from 5 mm to 8mm and different length from 30 mm to 120 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.
GII Spinal Fixation System Product Brochure.
Peer-reviewed clinical publications on the GII pedicle fixation system.