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.
Recommended Actions
- Determine system type(s) and applicable product codes
- Identify required mechanical testing based on system type
- Conduct testing on worst-case constructs with final, sterilized components
- Prepare comprehensive test reports with clear rationales
- Evaluate need for additional testing (wear, biocompatibility, aging) based on materials and design
- Develop required labeling including appropriate warnings
- Consider if clinical data is needed based on novelty and test results
- Prepare sterilization validation data
- Consider submitting separate 510(k)s for different systems
- 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
- Special 510(k) may be appropriate for certain modifications
- Separate 510(k)s generally recommended for different spinal systems
- Clear identification needed when using components from previously cleared systems
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
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