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Device
prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Review Panel
Orthopedic
Product Code
MRA
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
PMA
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
8-195 ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
8-226 ASTM F603-12 (Reapproved 2020)
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
8-494 ISO 6474-1 Second edition 2019-03
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
8-505 ISO 6474-2 Second edition 2019-03
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
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
11-277 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)]
11-314 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
11-337 ISO 16087 First edition 2013-10-01
Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
11-338 ISO 11491 First edition 2017-07
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
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
11-371 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
11-380 ASTM F2979-20
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
11-381 ASTM F2582-20
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
11-382 ASTM F3090-20
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
11-383 ASTM F3143-20
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
11-384 ASTM F3446-20
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
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)]
11-394 ASTM F1820-22
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
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
11-403 ASTM F3047M-23
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Third Party Review
Not Third Party Eligible
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