Product Classification

• Device: prosthesis, hip, hemi-, femoral, metal ball
• Regulation Description: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LZY
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3360
• 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

• 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
• 11-395 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