Post

Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (DRAFT)

This guidance applies to Class II and Class III orthopedic devices with metallic and/or calcium phosphate coatings. It specifically covers: - Metallic coatings manufactured using thermal spray, sintering, vapor deposition, additive manufacturing or other methods - Calcium phosphate coatings manufactured by plasma spray, solution precipitation, electrochemical deposition or other methods - Dual coatings combining both metallic and calcium phosphate layers The guidance does not cover other types of coatings (ceramic, other calcium-based) or surface modifications (etching, anodizing). Drug/biologic characterization is also out of scope.

This is a draft guidance. Not for implementation.

  1. Determine if device requires clinical data based on novelty and risk assessment
  2. Develop comprehensive coating characterization plan including:
    • Physical/chemical properties testing
    • Mechanical integrity testing
    • Biocompatibility evaluation
    • Sterility validation
  3. Establish specifications and acceptance criteria for coating properties
  4. Validate shelf life and packaging system
  5. Prepare labeling with appropriate indications and limitations
  6. Determine if changes to existing devices require new 510(k) submission
  7. Consider pre-submission consultation for novel technologies or testing approaches
  8. Document all testing and validation in format suitable for regulatory submission
  9. Maintain design history file with complete test reports and justifications
  10. Monitor post-market performance to confirm coating safety and effectiveness

Key Considerations

Clinical testing

  • Generally unnecessary except for novel technologies or when bench/animal testing raises concerns
  • IDE requirements apply if clinical investigation is needed
  • Real-world data may be acceptable in some cases

Non-clinical testing

  • Coating description including name, method, materials, structure, location
  • Mechanical testing for coating integrity and adhesion
  • Microstructural characterization
  • Chemical analysis and phase composition
  • Dissolution rate testing for calcium phosphate coatings
  • Substrate/device testing to evaluate coating process effects

Labelling

  • Must specify cementless implantation for calcium phosphate coated joint arthroplasty
  • Biological fixation claims only allowed for porous coatings meeting specific criteria
  • “Nano” claims require supporting characterization data

Biocompatibility

  • Required for all patient-contacting materials including substrate and coating
  • Testing based on implant devices with tissue/bone contact and long-term duration
  • Additional evaluation needed for novel coatings without predicate devices

Safety

  • Sterility validation required
  • Pyrogenicity testing needed
  • Shelf life and packaging validation required

Other considerations

  • ASTM F1854: Standard test method for stereological evaluation of porous coatings on medical implants
  • ASTM F1147: Standard test method for tension testing of calcium phosphate and metallic coatings
  • ASTM F1160: Standard test method for shear and bending fatigue testing of calcium phosphate and metallic coatings
  • ASTM F1978: Standard test method for measuring abrasion resistance of metallic thermal spray coatings
  • ISO 13779-1: Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite
  • ISO 13779-2: Implants for surgery — Hydroxyapatite — Part 2: Thermally sprayed coatings of hydroxyapatite
  • ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging
  • ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Original guidance

  • Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements
  • HTML / PDF
  • Issue date: 2024-01-23
  • Last changed date: 2024-01-22
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Orthopedic, Premarket
  • ReguVirta summary file ID: 6de88d437a50c0a62b70f009ad5f0b82
This post is licensed under CC BY 4.0 by the author.