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.
What You Need to Know? 👇
What specific characterization data is required for hydroxyapatite coating particle analysis in 510(k) submissions?
The FDA requires particle size and distribution data for both metal and HA powders, average porosity size, overall pore volume, and total surface area of the coated implant’s implantable portion.
How should bonding strength between hydroxyapatite and metal substrates be tested for regulatory submissions?
Bonding strength testing must include at least ten samples with standard deviation analysis. Detailed testing protocols and sample preparation methods must be provided to demonstrate statistical significance.
What imaging requirements exist for hydroxyapatite-coated orthopedic implants in 510(k) applications?
Scanning electron microscopy pictures are required showing metal particle surfaces, HA-coated surfaces, and cross-sectioned areas with coating thickness measurements and tolerances clearly documented.
Which analytical techniques are mandatory for characterizing hydroxyapatite coating crystallinity and purity?
X-ray diffraction patterns (Cu/Ka radiation, 4° to 60° scan) and infrared spectra are required before and after coating, including crystallographic interpretations and molecular band assignments.
What dissolution testing parameters must be evaluated for hydroxyapatite coatings in medical device submissions?
Solubility products at 37°C and dissolution rates in pH 7.3 buffered solution at 37°C must be measured, with pH changes recorded throughout testing.
How should substantial equivalence be demonstrated for hydroxyapatite-coated orthopedic implants?
A detailed tabulated comparison including size, geometry, materials, surface properties, bulk properties, and coating processes between your device and legally marketed predicate devices is required.
What You Need to Do 👇
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 ID: 226dc018e29df47290ff4e52efcb4825