Product Classification

• Device: prosthesis, wrist, hemi-, ulnar
• Regulation Description: Wrist joint ulnar (hemi-wrist) polymer prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KXE
• Premarket Review: Joint Arthroplasty Devices (DHT6A); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3810
• 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

• 8-368 ASTM F2625-10 (Reapproved 2016)
  Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
• 8-378 ASTM D792-13
  Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• 8-379 ISO 11542-2 First edition 1998-11-15
  Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
• 8-403 ASTM D638-14
  Standard Test Method for Tensile Properties of Plastics
• 8-404 ASTM E647-15
  Standard Test Method for Measurement of Fatigue Crack Growth Rates
• 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
• 11-197 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
• 11-366 ASTM F2381-19
  Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

Third Party Review

Not Third Party Eligible