OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Inclusion Criteria: * 5o years of age. * Legal US citizen with ability to read and write. * Acute painful fracture (≤2 months) between T6 to L5 as evidenced by plain radiography, CT / Bone scan, and/or magnetic resonance imaging. * Subject is... * Non-Standard Treatment: * Inability to tolerate prolonged conservative care due to intractable pain (VAS 70/100) with maximum tolerated medication for at least 2 weeks, but less than 6 weeks; OR * Inability to tolerate prolonged immobilization due to other comorbid conditions aggravated by immobility for at least 2 weeks, but less than 6 weeks; OR * Intolerance of or adverse reaction to available pain medications for at least 2 weeks, but less than 6 weeks; OR * Hospitalization secondary to pain for at least 2 weeks, but less than 6 weeks. * Standard Treatment: * Has undergone at least 6 weeks of conservative care. * Have a self assessment VAS score ≥ 50 mm at the Baseline visit. * Have 30% or greater disability score on ODI at the Baseline visit. * Anterior wedge deformity with no less than 5% and no more than 75% loss of anterior cortical height as compared to the posterior cortical height of the same vertebral body. * Bone mineral density (BMD) T-score of -1.5 or less, as determined by a DEXA scan. * Intact posterior cortical vertebral body wall. * Type A compression fractures according to AO classification of spinal vertebral fractures. * If a transpedicular approach is utilized the pedicle diameter must be equal to or greater than 6.5 mm; however, if an extrapedicular approach is utilized there is not a minimum pedicle width requirement. * Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study (HIPAA authorization) and to return for scheduled follow-up evaluations. Exclusion Criteria: * Significant vertebral collapse defined as more than 75% of original vertebral height or less than 5% or a burst or pedicle fracture with posterior cortical wall disruption. * Presence of healed fracture at the intended treatment level(s) based on a CT / bone scan or MRI. * Compression fractures requiring treatment at 3 or more levels. * Spinal/Foraminal canal compromised. * Significant deformity/instability indicated by: * Segmental kyphosis \> 30 degrees, or * translation \> 4 mm. * VAS back pain score of \< 50 mm. * ODI score of \< 30%. * Have a documented active systemic or local infection, such as AIDS, hepatitis, with a WBC greater than 11.5 and a temperature greater than 101.5°F. * Spinal surgery in the thoracic and/or lumbar region within the past year * Previous kyphoplasty or vertebroplasty at involved level or level above or below treated level. * Spinal arthrodesis within 2 adjacent levels of fracture. * Non-ambulatory prior to fracture. * Greater than Grade 1 spondylolisthesis at level of fracture. * Scoliosis \> 10 degrees. * BMI \> 40. * Severe cardiopulmonary deficiencies. * Pregnant. * Type I or II diabetes without controlled A1C level. * Achondrogenesis disorders. * Active malignancy, hemangiomas at the operative level(s), or multiple myeloma. * No generally accepted medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy with a threshold for INR at 1.5 or less, and platelet count 100,000. * A life expectancy less than the study duration or undergoing palliative care. * Trauma injuries aside from vertebral compression fracture(s). * Injuries that violate the posterior vertebral cortex and/or posterior column. * Active litigation. * Currently on workman's compensation. * Autoimmune disorders. * Non-spine pain that requires daily Opioids. * Systemic long-term steroid use - greater than 6 months. * Active multiple sclerosis or neurologic deficit caudal to fracture. * Currently an alcohol, solvent, or drug abuser. * Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements. * History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2) * Incarcerated. * Are currently participating in another investigational study. * Having had another device implanted in the thoracic and/or lumbar area that would interfere with the surgical approach, study device, or follow-up evaluations.