Product Classification

• Device: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Regulation Description: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: LPH
• Premarket Review: Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3358
• 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

• 8-195 ASTM F2024-10 (Reapproved 2016)
  Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 8-354 ASTM F1377-13
  Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
• 8-368 ASTM F2625-10 (Reapproved 2016)
  Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
• 8-378 ASTM D792-13
  Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• 8-379 ISO 11542-2 First edition 1998-11-15
  Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
• 8-380 ASTM F1160-14 (Reapproved 2017)e1
  Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• 8-403 ASTM D638-14
  Standard Test Method for Tensile Properties of Plastics
• 8-404 ASTM E647-15
  Standard Test Method for Measurement of Fatigue Crack Growth Rates
• 8-427 ASTM F1185-03 (Reapproved 2014)
  Standard Specification for Composition of Hydroxylapatite for Surgical Implants
• 8-429 ASTM F2224-09 (Reapproved 2020)
  Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• 8-493 ISO 13779-2 Third edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
• 8-515 ISO 13779-3 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity.
• 8-516 ISO 13779-4 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
• 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
• 11-239 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
• 11-272 ASTM F1714-96 (Reapproved 2018)
  Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• 11-275 ASTM F2381-10
  Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
• 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
• 11-293 ASTM F2582-14
  Standard Test Method for Impingement of Acetabular 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
• 11-307 ASTM F2385-15 (Reapproved 2019)
  Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
• 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
• 11-319 ISO 7206-12 First edition 2016-10-01
  Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
• 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) ]
• 11-342 ASTM F732-17
  Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• 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
• 11-366 ASTM F2381-19
  Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
• 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