Product Classification

• Device: prosthesis, elbow, constrained, cemented
• Regulation Description: Elbow joint metal/polymer constrained cemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: JDC
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3150
• 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
• 8-514 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
• 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
• 11-321 ASTM F2887-17
  Standard Specification for Total Elbow Prostheses
• 11-404 ASTM F2887-23
  Standard Specification for Total Elbow Prostheses

Third Party Review

Not Third Party Eligible