Post

Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions

This guidance addresses the requirements for 510(k) submissions of bone anchor (suture anchor) devices used in the appendicular skeleton for attaching soft tissue to bone. It specifically covers devices where attachment is achieved by connecting one end of a suture to soft tissue and the other end to a bone-anchored device. The guidance excludes anchors used for bone-to-bone attachment, interference screws, and anchors for artificial ligaments/tendons.

  1. Determine product classification and applicable product codes (MAI or MBI)
  2. Conduct comprehensive device characterization including dimensions and materials
  3. Perform required biocompatibility testing based on contact duration/type
  4. Complete mechanical performance testing suite
  5. Validate sterilization and packaging processes
  6. Prepare detailed labeling including indications and surgical technique
  7. Assess need for clinical data based on device novelty/risk
  8. Document any modifications requiring new 510(k) submission
  9. Validate shelf life claims through accelerated aging studies
  10. Evaluate MR compatibility if applicable

Key Considerations

Clinical testing

  • Clinical testing generally not required except for:
    • Dissimilar indications from legally marketed devices
    • New technology raising clinical performance questions
    • Cases where engineering/animal testing raises issues needing clinical evaluation
    • Devices with lower mechanical properties than predicates

Non-clinical testing

  • Insertion testing in worst-case bone/bone substitute
  • Pullout testing to evaluate tensile load failure modes
  • Component interconnection testing for multi-component anchors
  • Fatigue testing if cyclic loading expected
  • Degradation testing for absorbable anchors over twice the healing duration

Labeling

  • Must include adequate information for intended users
  • Specify anatomic locations for anchor components
  • Include detailed directions for use for trained specialists
  • Provide assembly and insertion instructions

Biocompatibility

  • Must evaluate all patient-contacting materials
  • Address cytotoxicity, sensitization, irritation, acute systemic toxicity
  • Include material-mediated pyrogenicity testing
  • Evaluate subchronic toxicity, genotoxicity, implantation
  • Assess chronic toxicity and carcinogenicity

Safety

  • Sterility validation required for sterile devices
  • Reprocessing validation for reusable components
  • Pyrogenicity testing for bacterial endotoxins
  • MR compatibility assessment for passive implants

Other considerations

  • ASTM F1839: Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
  • ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
  • ISO 10993-1: Biological evaluation of medical devices
  • ASTM F1635: Standard Test Method for in vitro Degradation Testing
  • ANSI/AAMI/ISO 11607-1: Packaging for terminally sterilized medical devices
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems

Original guidance

  • Bone Anchors (Suture Anchors) for Appendicular Skeleton - Content and Testing Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 2020-03-03
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Orthopedic, Premarket
  • ReguVirta summary file ID: 9216bbaab3d20333495f9f9d4ff0f47f
This post is licensed under CC BY 4.0 by the author.