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.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for orthopedic fracture fixation plates?
The Safety and Performance Based Pathway is an optional FDA submission route where manufacturers can demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than directly comparing their device to a predicate device, potentially reducing regulatory burden.
Which orthopedic fracture fixation plates are excluded from this guidance scope?
Plates for mandibular, maxillofacial, cranial, orbital, thorax, spine, pelvis, and femoral head/neck fractures are excluded. Also excluded are additively manufactured devices, resorbable devices, combination products, devices with coatings, and those with complex geometries or dynamic components.
What are the minimum bending strength requirements for different anatomical locations?
Requirements vary by location: Femur & Proximal Tibia (26.3 N-m), Humerus (11.6 N-m), Clavicle and Distal Tibia (11.9 N-m), Elbow (6.7 N-m), Fibula (2.3 N-m), Hand/Wrist/Forearm (1.6 N-m), and Foot (1.2 N-m).
What materials are acceptable for fracture fixation plates under this guidance?
Acceptable materials include various titanium alloys (ASTM F136, F1472, F1295, F67), stainless steel (ASTM F138, F139), and cobalt-chromium-molybdenum alloys (ASTM F1537). All materials must meet their respective ASTM specifications for surgical implant applications.
Is individual screw pullout testing required for plating systems?
No, FDA does not require individual screw pullout strength testing for plating systems because multiple screws are used to minimize en-bloc plate pull-out risk. Substantial equivalence can be demonstrated through screw comparison and construct fixation evaluation instead.
What biocompatibility endpoints must be evaluated for these implanted devices?
Required endpoints include cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, sub-acute/sub-chronic toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity, as these are permanent implants (>30 days) contacting tissue/bone.
What You Need to Do 👇
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