Product Classification

• Device: sacroiliac joint fixation
• Regulation Description: Smooth or threaded metallic bone fixation fastener.
• Definition: sacroiliac joint fusion
• Physical State: may be used with bone graft, should not be used with bone cement
• Technical Method: bridges both sides of the joint, preventing motion
• Target Area: sacroiliac joint
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: OUR
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3040
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-495 ISO 5834-3 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
• 8-496 ISO 5834-4 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
• 8-497 ISO 5834-5 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
• 8-501 ISO 5834-1 Fourth edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
• 8-514 ISO 5834-2 Fifth edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
• 8-572 ASTM F2565-21
  Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• 8-573 ASTM F2695-12(2020)
  Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• 11-398 ASTM F3574-22
  Standard Test Methods for Sacroiliac Joint Fusion Devices

Third Party Review

Not Third Party Eligible