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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.

  1. Determine the type of UHMWPE material being used (conventional, HXLPE, AO-HXLPE, or non-conventional)
  2. Perform material characterization testing based on UHMWPE type
  3. Conduct biocompatibility evaluation according to ISO 10993-1
  4. Validate package integrity and shelf life
  5. Submit Pre-Submission for non-conventional UHMWPE or when planning animal studies
  6. Prepare complete test reports following FDA’s recommended format
  7. Consider submitting a Pre-Submission to determine testing requirements for investigational devices
  8. Document all material processing steps and controls
  9. Validate sterilization process and package integrity
  10. 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

  • 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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