Product Classification

• Device: prosthesis, hip, semi-constrained (metal cemented acetabular component)
• Regulation Description: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: JDL
• Premarket Review: Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• Regulation Number: 888.3320
• 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

• 11-183 ASTM F1875-98 (Reapproved 2014)
  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
• 11-238 ASTM F2033-12
  Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Mateirals
• 11-239 ASTM F2345-03 (Reapproved 2013)
  Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• 11-267 ASTM F2009-00 (Reapproved 2011)
  Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
• 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
• 11-279 ASTM F2996-13
  Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
• 11-285 ASTM F2978-13
  Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
• 11-286 ASTM F2979-14
  Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
• 11-299 ASTM F2068-15
  Standard Specification for Femoral Prostheses - Metallic Implants
• 11-306 ASTM F1814-15
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 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)]
• 11-314 ISO 14242-2 Second edition 2016-09-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
• 11-320 ISO 7206-13 First edition 2016-07-01
  Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
• 11-337 ISO 16087 First edition 2013-10-01
  Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
• 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) ]
• 11-340 ASTM F3018-17
  Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• 11-344 ASTM F2580-18
  Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
• 11-349 ISO 14242-3 First edition 2009-03-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
• 11-352 ISO 14242-1 Third edition 2014-10-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
• 11-358 ISO 14242-4 First edition 2018-05
  Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
• 11-359 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
• 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

Third Party Review

Not Third Party Eligible