Product Classification

• Device: pin, fixation, smooth
• Regulation Description: Smooth or threaded metallic bone fixation fastener.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: HTY
• Premarket Review: Restorative, Repair and Trauma Devices (DHT6C); 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

• 8-495 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(2025)
  Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
• 11-74 ISO 5838-2 First edition 1991-01-15
  Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
• 11-75 ISO 5838-3 First edition 1993-09-15
  Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
• 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
• 11-252 ISO 5838-1 Third edition 2013-03-01
  Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
• 11-322 ASTM F1541-17
  Standard Specification and Test Methods for External Skeletal Fixation Devices
• 11-324 ASTM F366-17
  Standard Specification for Fixation Pins and Wires
• 11-325 ASTM F564-17
  Standard Specification and Test Methods for Metallic Bone Staples
• 11-378 ASTM F2502-17
  Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• 11-424 ASTM F983-24
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-425 ASTM F565-21
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-428 ASTM F1541-24
  Standard Specification and Test Methods for External Skeletal Fixation Devices
• 11-429 ASTM F366-24
  Standard Specification for Fixation Pins and Wires
• 11-430 ASTM F564-24
  Standard Specification and Test Methods for Metallic Bone Staples
• 11-438 ASTM F2502-24
  Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

Third Party Review

Not Third Party Eligible