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.
What You Need to Know? 👇
What are the key differences between the 2004 and 2000 FDA spinal system guidance documents?
The 2004 guidance redefined system types based on indications for use rather than product codes, restructured pedicle screw product codes (MNI for class II, NKB for class III preamendments, NKG for unclassified cervical), and updated testing recommendations and indications for pedicle screw systems.
Which spinal devices require PMA approval instead of 510(k) clearance?
Interbody fusion devices, non-fusion devices (cages), disc replacement devices, and other nonfusion spinal devices are Class III devices requiring PMA approval. These are considered significant risk devices requiring FDA-approved IDE studies before marketing.
What mechanical testing is required for anterior cervical spinal systems?
Anterior cervical systems require static and dynamic axial compression bending testing and static torsion testing. Additional information needed includes clarification of unilateral/bilateral fixation intent and comparison of worst-case construct width/prominence to predicate systems.
When are clinical studies required for spinal system 510(k) submissions?
Clinical studies are generally not required due to least burdensome provisions. However, they may be recommended for devices with new uses, novel design features, unfavorable mechanical testing results, or for cervical pedicle systems (NKG product code).
What specific labeling warnings are required for pedicle screw systems?
Pedicle screw systems must include warnings that safety/effectiveness are established only for significant mechanical instability/deformity requiring fusion with instrumentation, and precautions that implantation should only be performed by experienced spinal surgeons with specific training.
What additional testing is recommended for polymer-based spinal components?
Polymer components require material characterization (biocompatibility, molecular weight, crystallinity), exhaustive extraction analysis using polar and non-polar solvents, identification of leachables at ppb levels, potential aging studies, and possible animal testing for spine-specific material response.
What You Need to Do 👇
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