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Device
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Description
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWA
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
PMA
Regulation Number
888.3330
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
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)]
11-314 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
11-339 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
11-379 ASTM F2978-20
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
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
Guidance Document
Non-clinical Information for Femoral Stem Prostheses
Third Party Review
Not Third Party Eligible
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