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Facet Screw Systems - Safety and Performance Based Pathway

This guidance covers facet screw systems consisting of metallic bone screws and optional washer components intended for bilateral immobilization of facet joints to stabilize the spine as an aid to fusion. The devices must be made from titanium alloy (ASTM F136) and fall within specific dimensional ranges. The guidance excludes combination products, resorbable devices, coated devices, additively manufactured devices, devices with complex geometries or unique characteristics.

  1. Verify device dimensions fall within specified ranges
  2. Confirm material compliance with ASTM F136
  3. Conduct static cantilever bending testing per ASTM F2193
  4. Perform axial pullout strength engineering analysis
  5. Complete biocompatibility evaluation for all 10 required endpoints
  6. Validate sterilization process if device is provided sterile
  7. Validate reprocessing instructions if end-user sterilized
  8. Prepare documentation including test reports and Declarations of Conformity
  9. Consider Pre-Submission if additional testing beyond guidance scope is needed
  10. Prepare 510(k) submission following Safety and Performance Based Pathway format

Key Considerations

Non-clinical testing

  • Static cantilever bending testing per ASTM F2193
  • Axial pullout strength evaluation through engineering analysis
  • Specific acceptance criteria based on screw diameter (<4.5mm vs ≥4.5mm)

Biocompatibility

  • Testing required for 10 endpoints as permanent implant:
    • Cytotoxicity
    • Sensitization
    • Irritation
    • Acute systemic toxicity
    • Material-mediated pyrogenicity
    • Sub-acute/sub-chronic toxicity
    • Genotoxicity
    • Implantation
    • Chronic toxicity
    • Carcinogenicity

Safety

  • Sterilization validation required for sterile devices
  • Reprocessing validation required for end-user sterilized devices
  • Must achieve SAL of 10-6

Other considerations

  • ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications
  • ASTM F2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
  • 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 11607-1/2: Packaging for terminally sterilized medical devices
  • ISO 10993-1: Biological evaluation of medical devices

Original guidance

  • Facet Screw Systems - Safety and Performance Based Pathway
  • HTML / PDF
  • Issue date: 2022-04-13
  • Last changed date: 2022-04-12
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 799fea7b0e63422105f60573def6bb79
This post is licensed under CC BY 4.0 by the author.