Product Classification

• Device: prosthesis, hip, hemi-, femoral, metal
• Regulation Description: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KWL
• Premarket Review: Joint Arthroplasty Devices (DHT6A); 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

• 11-183 ASTM F1875-98 (Reapproved 2022)
  Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
• 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
• 11-277 ISO 7206-6 Second edition 2013-11-15
  Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
• 11-299 ASTM F2068-15
  Standard Specification for Femoral Prostheses - Metallic Implants
• 11-312 ISO 7206-4 Third edition 2010-06-15
  Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
• 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15
  Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
• 11-344 ASTM F2580-18
  Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
• 11-371 ASTM F2009-20
  Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
• 11-372 ASTM F2996-20
  Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
• 11-376 ASTM F2033-20
  Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
• 11-385 ASTM F2345-21
  Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• 11-389 ISO 7206-10 Second edition 2018-08
  Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-396 ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022]
  Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
• 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