Non-Spinal Metallic Fracture Fixation Plates - Safety and Performance Based Testing Requirements
This guidance covers Class II non-spinal fracture fixation plates intended for osteosynthesis in upper extremities, lower extremities, and clavicle. The plates must be manufactured from specific titanium, stainless steel, or cobalt-chromium alloys. The guidance excludes plates for mandibular, maxillofacial, cranial, orbital, thorax, spine, pelvis and femoral head/neck fractures, as well as devices with complex geometries, coatings, or novel features.
Recommended Actions
- Determine if your device falls within the scope of the guidance
- Identify worst-case configurations for mechanical testing
- Conduct required mechanical testing (four-point bending, screw testing)
- Perform biocompatibility evaluation
- Complete sterilization/reprocessing validation as applicable
- Prepare geometric comparison to predicate devices
- Document rationales for worst-case selections
- Compile test reports and declarations of conformity
- Consider Pre-Submission if device has unique features or new indications
- Prepare 510(k) submission following Safety and Performance Based Pathway format
Key Considerations
Non-clinical testing
- Static four-point bending testing per ASTM F382 with specific minimum bending strength and stiffness criteria for each anatomical location
- Torsional strength and driving torque testing for compatible screws
- Worst-case device configurations must be tested with minimum 5 samples
Labelling
- Must describe anatomical use location of each plate
- Must identify compatible screws for each plate
Biocompatibility
- Must evaluate endpoints for permanent implants (>30 days):
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogenicity
- Sub-chronic toxicity
- Genotoxicity
- Implantation
- Chronic toxicity
- Carcinogenicity
Safety
- Sterilization validation required for sterile devices
- Reprocessing validation required for end-user sterilized devices
- Must demonstrate sterility assurance level of 10-6
Other considerations
- Geometric comparison to predicate devices required
- Must provide rationale for worst-case design selection
- Testing should be performed on final, finished devices
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Testing Requirements for Orthopedic Implants with Modified Metallic Bone-Interface Surfaces
- Testing of Non-Articulating, Mechanically Locked Modular Implant Components in Orthopedic Devices
- 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
- ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
- ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws
- 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: Packaging for terminally sterilized medical devices – Part 1
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
- ISO 10993-1: Biological evaluation of medical devices
Original guidance
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