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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
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
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Third Party Review
Not Third Party Eligible
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