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Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions

This guidance applies to plate and rod-based spinal systems indicated for fusion, as well as vertebral body replacement devices. It covers: - New spinal systems - Components to be added to cleared spinal systems - Expansion of indications for cleared spinal systems The guidance does not address facet screw fixation systems, interbody fusion devices, non-fusion devices (like disc replacements), or other non-fusion spinal devices.

  1. Determine system type(s) and applicable product codes
  2. Identify required mechanical testing based on system type
  3. Conduct testing on worst-case constructs with final, sterilized components
  4. Prepare comprehensive test reports with clear rationales
  5. Evaluate need for additional testing (wear, biocompatibility, aging) based on materials and design
  6. Develop required labeling including appropriate warnings
  7. Consider if clinical data is needed based on novelty and test results
  8. Prepare sterilization validation data
  9. Consider submitting separate 510(k)s for different systems
  10. Clearly document use of any previously cleared components

Key Considerations

Clinical testing

  • Generally not required for most spinal systems
  • May be recommended if device has:
    • New uses
    • Novel design features
    • Unfavorable mechanical testing results
  • Required for cervical pedicle screw systems (NKG product code)

Non-clinical testing

  • Static and dynamic mechanical testing recommended based on system type
  • Testing should be performed on worst-case constructs
  • Test reports should include rationale for components tested, loading modes, and test configuration
  • Wear testing recommended for systems with:
    • Novel materials (polymers, composites)
    • Articulating components

Labeling

  • Package label should include:
    • Component name
    • Reference to package insert
    • Part/lot number
    • Shelf life if applicable
    • Material
    • Sterility status
  • Package insert should include:
    • Indications for use
    • Precautions and warnings
    • Device description
    • Sterilization information
  • Surgical technique manual recommended for unique designs

Biocompatibility

  • Required for novel materials
  • Should follow ISO 10993
  • Additional testing may be needed for polymers including:
    • Material characterization
    • Leachables testing
    • Aging studies

Safety

  • Sterility information required per FDA guidance
  • Shelf life studies needed for materials affected by aging
  • Warning statements required for pedicle screw systems

Other considerations

  • ASTM F1717: Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1798: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
  • ISO 10993: Biological Evaluation of Medical Devices

Original guidance

  • Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 2004-05-02
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 1ec86c4a8e80850ee31601a0ad90b988
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