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Checklist for Orthopedic External Fixation Device Submissions

This guidance provides a checklist for reviewing orthopedic external fixation devices submissions, focusing on the comparison with predicate devices and testing requirements. It covers devices used for fixation of fractures, joint fusion, and surgical procedures involving bone cutting.

  1. Identify and document the bone construct classification and frame configurations
  2. Compare intended use with predicate devices
  3. List and classify all fixator elements according to ASTM F 1541
  4. Document detailed material and design descriptions for each component
  5. Conduct required mechanical testing based on design differences from predicate
  6. Ensure biocompatibility testing for any new materials
  7. Prepare comprehensive test reports following the suggested format
  8. Document all similarities and differences with predicate devices
  9. Address potential risks and complications
  10. Ensure compliance with labeling requirements

Key Considerations

Non-clinical testing

  • Static load to failure testing required for new designs with significantly different rigidity from predicates
  • Rigidity evaluation required if new device has lower estimated rigidity than predicate
  • Interconnection loosening evaluation needed for new interconnection designs
  • Fatigue testing required for designs with stress risers not present in predicate

Labelling

  • Must follow “Device Labeling Guidance” in the ODE Blue Book

Biocompatibility

  • Smooth or threaded fixation pins must demonstrate biological response at least as good as predicate when tested according to ISO 10993

Safety

  • Must address common complications including:
    • Pin-tract infection
    • Ring sequestrae
    • Prolonged healing
    • Distraction of fracture site
    • Delayed union
    • Bone fracture

Other considerations

  • ASTM F 1541: Standard Classification of External Skeletal Fixators
  • ISO 10993: Biological evaluation of medical devices
  • ISO 5832-3: Implants for surgery - Metallic materials

Original guidance

  • Checklist for Orthopedic External Fixation Device Submissions
  • HTML / PDF
  • Issue date: 1997-02-20
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: e4d0cf980d27ba26160efc626275346c
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