Hydroxyapatite Coated Orthopedic Implants - Information for 510k Submissions
This guidance outlines the specific information required in 510(k) submissions for orthopedic implants with hydroxyapatite (HA) coatings. It focuses on the technical and analytical data needed to demonstrate substantial equivalence to legally marketed devices.
Recommended Actions
- Develop a comprehensive testing plan covering all required chemical and physical analyses
- Establish protocols for sample preparation and testing methodologies
- Document detailed coating process parameters and quality control measures
- Prepare comparative analysis with predicate devices
- Ensure statistical significance in all analytical testing (minimum 10 samples where specified)
- Maintain detailed records of all testing conditions, particularly temperature and pH measurements
- Create a detailed technical file containing all required analytical data and characterizations
- Implement processes for crystallinity improvement and document their validation
- Establish specifications for coating thickness and bonding strength with appropriate tolerances
Key Considerations
Non-clinical testing
- Chemical analysis of HA powders before and after coating, including Ca/P ratios and elemental analysis
- Bonding strength testing between HA and titanium alloy or metal (minimum 10 samples)
- Solubility products measurement of HA particles at 37°C
- Dissolution rate testing of HA particles in pH 7.3 buffered solution at 37°C
- X-ray diffraction analysis of HA before and after coating
- Infrared spectral analysis of HA before and after coating
Other considerations
- Particle size and distribution data for metal and HA powders
- Surface characterization including SEM images and coating thickness measurements
- Detailed processes for improving HA crystallinity and purity after coating
- Comparative analysis with legally marketed devices including size, geometry, materials, surface properties, and coating processes
Relevant Guidances
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (Draft)
Related references and norms
- No specific norms or standards are referenced in this guidance
Original guidance
- Hydroxyapatite Coated Orthopedic Implants - Information for 510k Submissions
- HTML
- Issue date: 1997-02-19
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 226dc018e29df47290ff4e52efcb4825
This post is licensed under CC BY 4.0 by the author.