DESCRIPTION
The Inertia® Pedicle Screw and Deformity Correxxion System consists of rods,pedicle screws, hooks, connectors and set screws. Rods are available in either straight or pre-contoured (curved) forms in a variety of lengths. Pedicle screws are available in monoaxial, polyaxial, uniplanar and double thread versions in a variety of diameter-length combinations. Connectors include rod-rod and
rod-anchor. Set screws are used to fasten the rod, pedicle screw and/or
connectors. All implant components are manufactured from titanium alloy
(Ti-6AL-4V ELI) per ASTM F136 and optional spinal rods from cobalt chromium
alloy per ASTM F1537.
INDICATIONS FOR USE
The Inertia® Pedicle Screw and Deformity Correxxion System is intended for
pedicle and non-pedicle immobilization and stabilization of the posterior
non-cervical spine (T1-S2/Ilium) 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric
patients, the Inertia® Pedicle Screw and Deformity Correxxion System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The Inertia® Pedicle Screw and Deformity Correxxion System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach