MASADA Modular Spinal Fixation System

The MASADA Modular Spinal Fixation System is a posterior spinal fixation device composed of pedicle screws (polyaxial and monoaxial), rods, connectors, sublaminar bands, and hooks. It is intended to immobilize and stabilize the non-cervical spine in skeletally mature patients as an adjunct to fusion for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, and failed previous fusion. The system also includes navigated instruments for precise screw placement during open or minimally invasive procedures.

The device uses titanium alloys (Ti-6Al-4V ELI, CP Titanium Grade 4), cobalt-chromium alloys (CoCrMo, Elgiloy), nitinol, and PET materials. It comprises a modular system with polyaxial and monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks, supported by a comprehensive surgical instrument set. The navigated instruments are designed for use with the Medtronic StealthStation® System for stereotactic guidance.

The document cites ASTM material standards: ASTM F136 (Ti-6Al-4V ELI), ASTM F67 (CP Titanium Grade 4), ASTM F1537 (CoCrMo), ASTM F1058 (Elgiloy CoCrNi), ASTM F2063 (Nitinol #1), and ISO 10993 (PET biocompatibility). No specific mechanical or performance test standards are explicitly named in this summary.

Substantial equivalence is claimed based on similarities to the primary predicate (MASADA K231694) and additional predicates in principles of operation, technology, materials, and indications for use. An engineering analysis determined that no new worst-case conditions were introduced compared to the previously cleared K231694 submission. The device shares identical intended use, design approach, and material composition with predicates, establishing equivalence without new safety or performance risks.