Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
This guidance covers anterior cervical or anterior/lateral thoracolumbar spinal plating systems, which are Class II devices regulated under 21 CFR 888.3060. These devices are intended for fixation to vertebral bodies for spine stabilization and fusion. The guidance specifically excludes posterior spine plates, occiput plates, and devices with specific features like coatings, resorbable materials, or motion-allowing designs.
Recommended Actions
- Verify device design falls within scope and dimensional requirements
- Conduct mechanical testing per ASTM F1717 on worst-case configurations
- Validate sterilization process and packaging system
- Complete biocompatibility evaluation
- Prepare documentation demonstrating conformity to performance criteria
- Consider Pre-Submission if additional testing beyond guidance scope is needed
- Prepare test results summaries and Declarations of Conformity
- Ensure all manufacturing processes and materials meet specified ASTM standards
- Verify packaging and labeling meet requirements
- Submit comprehensive 510(k) package following Safety and Performance Based Pathway format
Key Considerations
Non-clinical testing
- Static compression bending testing per ASTM F1717 with specific performance criteria for cervical and thoracolumbar systems
- Static torsion testing per ASTM F1717 with defined acceptance criteria
- Dynamic compression bending fatigue testing per ASTM F1717 with minimum runout load requirements
- Testing should be performed on worst-case designs
- Minimum sample sizes required (5 samples for static tests, 6 for dynamic tests)
Labelling
- Must include sterilization validation information if labeled as sterile
- Must include reprocessing instructions if end-user sterilized
Biocompatibility
- Must evaluate endpoints for implant devices with permanent contact (>30 days)
- Required endpoints include cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, sub-chronic toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity
- Testing may be waived if using identical materials and processes as predicate device
Safety
- Must meet dimensional requirements specified in Table 1 of the guidance
- Must demonstrate sterility assurance level of 10-6 for sterile devices
Other considerations
- Device must be constructed from specified titanium alloys conforming to ASTM standards
- Packaging must maintain sterility and meet ISO 11607 requirements
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
Related references and norms
- ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- 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
- Spinal Plating Systems - Safety and Performance Based Testing for Anterior Cervical and Anterior/Lateral Thoracolumbar Devices
- HTML / PDF
- Issue date: 2020-12-11
- Last changed date: 2020-12-10
- Status: FINAL
- Official FDA topics: Medical Devices, 510(k), Orthopedic, Premarket
- ReguVirta summary file ID: 1dfef89ee3a7c7b722a3427db1e0f769
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