Product Classification

• Device: prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
• Regulation Description: Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: JDH
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• Regulation Number: 888.3380
• Device Class: 3
• 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

• 11-394 ASTM F1820-22
  Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-401 ISO 21535 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

Guidance Document

• Non-clinical Information for Femoral Stem Prostheses

Third Party Review

Not Third Party Eligible