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Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements

This guidance covers Class II non-spinal fracture fixation plates intended for osteosynthesis in upper extremities, lower extremities, and clavicle. The plates must be manufactured from specific titanium, stainless steel, or cobalt-chromium alloys. The guidance excludes plates for mandibular, maxillofacial, cranial, orbital, thorax, spine, pelvis and femoral head/neck fractures, as well as devices with complex geometries, coatings, or novel features.

  1. Determine if your device falls within the scope of the guidance
  2. Identify worst-case configurations for mechanical testing
  3. Conduct required mechanical testing (four-point bending, screw testing)
  4. Perform biocompatibility evaluation
  5. Complete sterilization/reprocessing validation as applicable
  6. Prepare geometric comparison to predicate devices
  7. Document rationales for worst-case selections
  8. Compile test reports and declarations of conformity
  9. Consider Pre-Submission if device has unique features or new indications
  10. Prepare 510(k) submission following Safety and Performance Based Pathway format

Key Considerations

Non-clinical testing

  • Static four-point bending testing per ASTM F382 with specific minimum bending strength and stiffness criteria for each anatomical location
  • Torsional strength and driving torque testing for compatible screws
  • Worst-case device configurations must be tested with minimum 5 samples

Labelling

  • Must describe anatomical use location of each plate
  • Must identify compatible screws for each plate

Biocompatibility

  • Must evaluate endpoints for permanent implants (>30 days):
    • Cytotoxicity
    • Sensitization
    • Irritation
    • Systemic toxicity
    • Pyrogenicity
    • Sub-chronic toxicity
    • Genotoxicity
    • Implantation
    • Chronic toxicity
    • Carcinogenicity

Safety

  • Sterilization validation required for sterile devices
  • Reprocessing validation required for end-user sterilized devices
  • Must demonstrate sterility assurance level of 10-6

Other considerations

  • ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ISO 17665-1: Sterilization of health care products – Moist heat
  • ISO 11135-1: Sterilization of health care products – Ethylene oxide
  • ISO 11137-1: Sterilization of health care products – Radiation
  • ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
  • ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
  • ISO 10993-1: Biological evaluation of medical devices

Original guidance

  • Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements
  • HTML / PDF
  • Issue date: 2022-04-11
  • Last changed date: 2022-04-08
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: fcf1b024f82e22b5eded12acc6de22e0
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