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The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion

The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the 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. All implants are manufactured from Ti-alloy per ASTM F136.

The Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware. 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The purpose of this submission is to request clearance for the new Pitkar Sixafix System. The Pitkar Sixafix System includes a web based software that is designed to assist the physician in performing precise deformity or fracture reduction and should always be used with hardware. The Sixafix System software receives inputs from measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity. To guide the surgeon, detailed information is provided in Software manual. The implantable components are manufactured from Stainless Steel per ASTM F138. The system will be provided in non-sterile configuration and will require steam sterilization prior to use.

Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

The purpose of this submission is to request clearance for the new Pitkar Locked Plating System. The Pitkar Locked Plating System implants are designed to address fractures of the humerus, radius, ulna, femur, tibia, fibula, and clavicle. The system is comprised of plates, screws and instruments to facilitate the installation of the implants. The plates and screws are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The Pitkar External Fixation System is indicated for both adults and pediatric patients for: 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The purpose of this submission is to request clearance for the new Pitkar External Fixation System. The implantable components are manufactured from Stainless Steel per ASTM F899. The system will be provided in non-sterile configuration and will require to be steam sterilized by the user prior to use.