Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
This guidance applies to class II and class III orthopedic devices, including spinal devices, that contain UHMWPE (Ultra-High Molecular Weight Polyethylene). It provides recommendations for characterization and testing of different types of UHMWPE materials: conventional UHMWPE, highly crosslinked UHMWPE (HXLPE), antioxidant highly crosslinked UHMWPE (AO-HXLPE), and non-conventional UHMWPE.
Recommended Actions
- Determine the type of UHMWPE material being used (conventional, HXLPE, AO-HXLPE, or non-conventional)
- Perform material characterization testing based on UHMWPE type
- Conduct biocompatibility evaluation according to ISO 10993-1
- Validate package integrity and shelf life
- Submit Pre-Submission for non-conventional UHMWPE or when planning animal studies
- Prepare complete test reports following FDA’s recommended format
- Consider submitting a Pre-Submission to determine testing requirements for investigational devices
- Document all material processing steps and controls
- Validate sterilization process and package integrity
- Develop a comprehensive shelf-life testing program including both accelerated and real-time aging studies
Key Considerations
Non-clinical testing
- Material characterization testing based on UHMWPE type
- Mechanical properties testing (tensile, impact resistance, density)
- Chemical properties testing (crystallinity, melting temperature, oxidation index)
- Fatigue resistance testing
- Wear testing for articulating components
- Shelf-life testing
Labelling
- Shelf life and expiration date
- Sterilization method
- Storage conditions
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material-mediated pyrogenicity
- Subchronic toxicity
- Genotoxicity
- Implantation
- Chronic toxicity
- Carcinogenicity
Safety
- Package integrity testing
- Sterilization validation
- Stability testing during shelf life
Other considerations
- Starting resin identification
- Resin consolidation method
- Terminal sterilization method
- For AO-HXLPE: antioxidant concentration and stability
- For non-conventional UHMWPE: additional specific testing based on material properties
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
- Shelf Life and Stability Testing for Medical Devices
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- ASTM F648: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ASTM F2759: Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene Used in Orthopedic and Spinal Devices
- ASTM F2565: Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Original guidance
- Testing and Characterization of Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
- HTML / PDF
- Issue date: 2019-04-26
- Last changed date: 2019-04-24
- Status: FINAL
- Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510(k), Orthopedic
- ReguVirta summary file ID: eeb480b7d0328f4205af0ec82b115e5c
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