Zimmer Spine’s TiTLE 2 Polyaxial Spinal System is a versatile solution for single or multi-level fixation. Straightforward instrumentation facilitates compression, distraction and reduction, while allowing for either an open or minimally invasive approach. When guided screw placement is required, the TiTLE 2 system also features cannulated polyaxial screws, an ideal option for use with the FlexPosure ® Portal during less invasive procedures.
The TiTLE 2 Poly Axial Spinal System Implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion. The components of the system are manufactured from Titanium that complies with ASTM F136 Standard for Ti 6Al-4V ELI. Some instruments supplied with this package insert are intended for single use only; refer to product label to determine if the instrument is intended for single use only. Refer to the Surgical Technique Manual for additional information on how to use these devices.
The System is equipped with components which are provided NON-STERILE. IMPLANTS ARE PROVIDED CLEAN AND MUST BE STERILZED PRIOR TO USE. INSTRUMENTS SHOULD BE CLEANED AND STERILIZED PRIOR TO USE.
Torque limiting instruments are designed to deliver a preset torque value when rotated in the clockwise direction. When the preset torque value is reached the instrument is designed to release. The handle will rotate approximately 30 degrees and the instrument is then reset to deliver the preset torque value again.
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the Thoracic, Lumbar and Sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The TiTLE 2 Poly Axial Spinal System can also be linked to the Minit ® Posterior Cervical and Upper Thoracic Fixation System.
Contraindications include but are not limited to:
Pre-operatively, the patient should be made aware of the possible adverse effects of spinal implant surgery. Additional surgery may be necessary to correct some of these effects.
NOTE: The TiTLE 2 Poly Axial Spinal System Surgical Guide and NorthStar™ Cannulated Screw Delivery System Surgical Guide (as appropriate) should be carefully followed. It supplies important additional information on the proper usage of the implants and instruments.