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.
What You Need to Know? 👇
What are the key testing requirements for orthopedic external fixation devices under FDA review?
Testing requirements include rigidity measurements, static failure testing, fatigue testing for stress risers, loosening evaluation for interconnections, and biocompatibility testing per ISO 10993 for new materials. Testing needs depend on design differences from predicate devices.
How does ASTM F 1541 classification help in external fixation device submissions?
ASTM F 1541 provides standardized terminology for describing bone construct classifications, frame configurations, and fixator elements. This classification system ensures consistent communication between manufacturers and FDA reviewers during the 510(k) review process.
What materials are typically acceptable for external fixation pins and components?
Acceptable materials include medical grade CoCrMo, Ti6Al4V, and 316 LVM stainless steel for pins contacting body tissues. New materials must demonstrate biocompatibility equivalent to predicate devices through ISO 10993 testing.
When is mechanical testing not required for external fixation devices?
Mechanical testing may not be required when the device has essentially the same design and materials as the predicate device, unless new safety concerns arise. Devices with identical rigidity and materials typically don’t need additional testing.
What complications should be considered when reviewing external fixation devices?
Common complications include pin-tract infection, ring sequestrae, prolonged healing, fracture site distraction, delayed union, and bone fracture. Reviewers must assess how design differences might affect these risk factors.
Which external fixation devices require special FDA review beyond third-party assessment?
Devices for spinal use, dynamitization during healing, those with significantly lower structural rigidity than predicates, or devices claiming MRI compatibility require direct FDA review due to complex risk analysis requirements.
What You Need to Do 👇
Recommended Actions
- Identify and document the bone construct classification and frame configurations
- Compare intended use with predicate devices
- List and classify all fixator elements according to ASTM F 1541
- Document detailed material and design descriptions for each component
- Conduct required mechanical testing based on design differences from predicate
- Ensure biocompatibility testing for any new materials
- Prepare comprehensive test reports following the suggested format
- Document all similarities and differences with predicate devices
- Address potential risks and complications
- 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
- Devices for spine use, dynamization during bone healing, or claiming MRI compatibility require special analysis
- Must identify bone types for attachment and frame configurations
- Must classify and describe all fixator elements according to ASTM F 1541
Relevant Guidances đź”—
- Device Labeling Requirements and Content for Premarket Approval Applications
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Orthopedic Device Metallic and Calcium Phosphate Coatings: Testing and Characterization Requirements (Draft)
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Non-Clinical Testing and Labeling Requirements for Femoral Stem Prostheses in Hip Replacement Systems
- Clinical Data Presentation for Orthopedic Implant Device Submissions
- Class II Non-Spinal Metallic Bone Screws and Washers - Safety and Performance Based Pathway
- Technical Considerations for Non-Spinal Metallic and Polymer Bone Plates and Screws
Related references and norms đź“‚
- ASTM F 1541: Standard Classification of External Skeletal Fixators
- ISO 10993: Biological evaluation of medical devices
- ISO 5832-3: Implants for surgery - Metallic materials