Talkeetna

Lumbar Pedicle Screw System

TALKEETNA® 5.5 Lumbar Pedicle Screw System

Purpose

The TALKEETNA 5.5 Lumbar Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

Device Description

The TALKEETNA 5.5 Lumbar Pedicle Screw System consists of a variety of shapes and sizes of rods, screws, and crosslinks which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The TALKEETNA 5.5 Lumbar Pedicle Screw System is a posterior lumbar pedicle screw system composed of medical grade titanium Ti-Alloy (Ti-6A-14V ELI) components. The 5.5mm titanium rods are available in a variety of lengths, addressing multiple levels of fixation. The pedicle screws are top-loading screws that come in multiple diameters and lengths in fixed-axial and multi-axial designs to accommodate anatomical variation when securing the rod/screw construct to the posterior lumbar vertebral bodies. The rod/screw interface provides a rigid construct that is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal lumbar lordosis, the rods are contoured to the desired lordotic curve. Various instruments are available to facilitate the implantation of the device.

Intended Use

The TALKEETNA 5.5 Lumbar Pedicle Screw System treats a variety of conditions of the Thoracolumbar spine. The system offers consistent reproducible fixation required for spinal arthrodesis while minimizing screw bulk and footprint. This makes for an ideal implant, allowing for adequate decortication and fusion bed preparation, space for parallel distraction/compression and in-situ bending. TALKEETNA 5.5 Lumbar Pedicle Screw System instrumentation was designed to improve surgeon comfort in the OR.

Indications for Use

The TALKEETNA 5.5 Lumbar Pedicle Screw System is intended for posterior, non-cervical fixation of 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.

Ti Alloy Axial Screws

The Talkeetna Posterior Lumbar Fixation System consists of a variety of shapes and sizes of rods, screws, Crosslinks which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The Talkeetna Posterior Lumbar Fixation System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. AXIS360 Surgical Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.

More Information

Instructions for Use
Surgical Technique