Apex Orthopaedic Technologies LLC

R-fix (rib-fixation) Spinal Growth System for Early-onset Spinal Deformity - Project Summary Early-onset Spinal Deformity Is a Subset of Pediatric Spinal Deformity That Begins Before the Age of 10 Years. Unlike Adolescent Idiopathic Scoliosis, It Is a Life-threatening Disease, Which Makes Early Intervention Crucial. Surgical Intervention Must Accommodate the Growth of the Developing Spine, Making This One of the Most Challenging Orthopedic Conditions to Treat. Current Intra-spinal Based Treatments, Such as Growing Rods With Pedicle Screw Fixation, Have High Complication Rates and Limited Effectiveness. the R-fix (rib-fixation) Spinal Growth System Is an Alternative Extra-spinal Technique That Uses Rib-based Fixation for Correcting Early-onset Spinal Deformity. This Extra-spinal Rib Fixation Is a Paradigm Shift From Seeking Correction of the Spine to Emphasizing Correction of Thorax Malalignment. the R-fix System Originated From a Bioengineering Lab (one of the Applicants' Labs) at Clemson University and Has Been Further Developed by Apex Orthopaedic Technologies. the R-fix Spinal Growth System Has Been Granted Breakthrough Device Designation by the Fda. the Objective of This Sbir Phase Ii Award Is Threefold: 1) Complete the Final Design, Manufacturing, and Quality Control Processes for the New R-fix System Components, 2) Obtain the Necessary Biomechanical, Biocompatibility, and Sterility Data Resulting in Successful 510(K) Clearance of the R-fix System, and 3) Demonstrate the Safety and Efficacy of New R-fix Uni-axial Rib Hook and Rib Band Designs in an Animal Model. This Research Will Be Conducted Over 24 Months and the Data Obtained From This Grant Proposal Will Result in a 510(K) Application for Fda Clearance and Follow-up Niams Pediatric Medical Device Initiative Clinical Trial Application. Major Milestones to Be Achieved With This Grant Include 1) Validation of New Implantable R-fix Components With Surgeon Feedback, 2) Completion of Benchtop Performance Testing and Fda 510(K) Submission, and 3) Assessment of the Safety and Efficacy of New R-fix Components Compared to Pedicle Screws in a Pediatric Hyperkyphosis Porcine Animal Model.