Finite element analysis of Orthopedic Implants
FEA & CFD Based Simulation Design Analysis Virtual prototyping MultiObjective Optimization
An orthopedic implant is a device surgically placed into the body designed to restore function by replacing or reinforcing a damaged structure. For the treatment of back pain, orthopedic implants such as bone plates and bone screws are used in spinal fusion surgery and fixation of fractured bone segments, as well as implant components used for hip and joint replacement. The material used in orthopedic implants must be biocompatible to avoid rejection by the body. Other risks associated with orthopedic implants include implants coming loose or breaking in the bone causing painful inflammation and infection to surrounding tissue.
FDA submissions require a comprehensive audit trail which includes:
- Records of all simulation data
- Revision management and control
- Correlation with physical test results
- Proven repeatable methods
- Software version tracking
To ensure confidence in the simulation and reliability of the analysis results, medical device manufacturers must ensure that the CAE analyst is using the most current CAD geometry, specify the correct material properties, and apply the appropriate environmental loading conditions. They must also create the proper mesh type and size, record the version of the analysis software, and correlate results with physical test data. These criteria must be preserved and managed for FDA compliance purposes and for the benefit of enhanced enterprise productivity.
FEA Simulation of Spine Implants
Enteknograte conducts FE modeling to evaluate in situ stress states of implantable spinal devices and surrounding biological structures, and to explore natural and device associated spinal kinematics. Results from these analyses, combined with data from our retrieval collection and cadaveric spine simulator, provide valuable insight into performance and potential failure modes for spine implant devices.
- Subject-specific anatomy based on medical imaging
- Non-homogeneous bone moduli based on bone mineral density (via calibrated CT)
- Robust contact algorithms for implant and facet interactions
- Analysis of total disc replacement impingement mechanics
- Evaluation of implant functionality
Enteknograte’s expertise covers technical issues from all major joint replacement interventions and orthopedic bone trauma. Specific FE experience includes the following:
- Models have been developed analyzing hip, knee, ankle, shoulder, elbow, wrist, finger and toe joint replacements
- Experience developing models to analyze fracture fixation for trauma
- Subject-specific anatomy based on medical imaging
- Non-homogeneous bone moduli based on bone mineral density
- Robust contact algorithms for implant and bone interactions
- Customized implant geometries
- Virtual experiments to simulate implantation of devices
- Parametric analysis to account for variations in design, surgical, and patient factors
- Topological shape optimization for load bearing medical devices
- Development of kinematic gait models for the evaluation of orthotic and high performance footwear
Enteknograte offers a Virtual Engineering approach with CFD and FEA tools such as Ansys Fluent, StarCCM+ for flows simulation and FEA based Codes such as ABAQUS, Ansys, Nastran and LS-Dyna, encompassing the accurate prediction of in-service loads, the performance evaluation, and the integrity assessment including the influence of manufacturing the components.
