Product Classification

• Device: screw, fixation, bone
• Regulation Description: Smooth or threaded metallic bone fixation fastener.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: HWC
• Premarket Review: Office of Orthopedic Devices (OHT6); Restorative, Repair and Trauma Devices (DHT6C)
• 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

• 8-475 ASTM F2026-17
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 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
• 8-558 ASTM F3333-20
  Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 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
• 8-574 ASTM F2820-12(2021)e1
  Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 8-577 ISO 13179-1 Second Edition 2021-09
  Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
• 8-609 ASTM F2026-23
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-242 ASTM F1839-08 (Reapproved 2016)
  Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
• 11-327 ASTM F543-17
  Standard Specification and Test Methods for Metallic Medical Bone Screws
• 11-363 ASTM F897-19
  Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
• 11-378 ASTM F2502-17
  Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

Guidance Documents

• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway

Third Party Review

Not Third Party Eligible