Effortmed, LLC · Class II · Cleared Jan 15, 2025
| K-number | K243946 |
| Device name | EffortMed Spinal Fixation System |
| Applicant | Effortmed, LLC |
| Product code | NKB |
| Device class | Class II |
| Decision date | Jan 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The EffortMed Spinal Fixation System is a posterior spinal fixation device consisting of polyaxial and monoaxial pedicle screws, rods, connectors, hooks, and setscrews made from titanium alloy. It is intended to provide stabilization and support spinal fusion in skeletally mature and pediatric patients with conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, and pseudoarthrosis.
The EffortMed system is a top-loading, multiple component posterior spinal fixation system with polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, straight and curved rods, connectors, hooks, and setscrews. All components are fabricated from titanium alloy (Ti6Al4V-ELI) conforming to ASTM F136 and supplied non-sterile for single use.
ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), ASTM F1798 (Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants), ASTM F543 (Test Methods for Metallic Medical Bone Screws), and tulip-dissociation testing for interconnection strength.
The EffortMed system has identical indications for use, materials, operating principles, design/geometry, dimensions, and sterility characteristics as the predicate devices (Msfx MIKRON and Cortera systems). Technological comparison shows no differences across all evaluated parameters. Non-clinical testing demonstrated equivalent performance using the same ASTM standards as predicates, establishing that the device performs substantially equivalently to legally marketed predicate devices.
View the full FDA submission: accessdata.fda.gov