INS-108 Rev C
03/2021
Page 1 of 8
KODIAK
TM
SPINAL FIXATION SYSTEM
INSTRUCTIONS FOR USE
GENERAL INFORMATION:
The Kodiak Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion
for the treatment of degenerative disease, deformity, and trauma indications.
The Kodiak Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, hooks, connectors,
and cross connectors that provide temporary internal fixation and stabilization during bone graft healing and/or
fusion mass development. The screws, hooks, connectors, and cross connectors are manufactured from surgical
grade titanium alloy (Ti-6Al-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and
cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
If additional levels of fixation are required, the Kodiak Spinal Fixation System rods may be used in conjunction
with Alphatec
Spine’s Solanas
®
Posterior System, which may connect to the Avalon
®
Occipital Plate System. The
Kodiak Cross Connectors accept various rod diameters, and are appropriate for use with Alphatec Spine’s 5.5
mm diameter rod-based systems, including the Arsenal Spinal Fixation System and the Zodiac
®
Spinal Fixation
System.
INDICATIONS FOR USE:
The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as
an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.,
fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor;
pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Kodiak Spinal Fixation
System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis.
Additionally, the Kodiak Spinal Fixation System is intended to treat pediatric patients diagnosed with the following
conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or
failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.
CONTRAINDICATIONS:
The system is contraindicated for:
1. Use in the cervical spine
2. Use with bone cement
3. Patients with allergy to titanium or cobalt chrome
4. Patients with osteopenia, bone absorption, bone and/or joint disease, deficient soft tissue at the wound site
or probable metal and/or coating intolerance
5. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental
illness, and/or other medical conditions, which would prohibit beneficial surgical outcome
6. Patients resistant to following postoperative restrictions on movement especially in athletic and occupational
activities
7. Spinal surgery cases that do not require bone grafting and/or spinal fusion
8. Reuse or multiple uses
