Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Product Classification
FDA Home
Medical Devices
Databases
-
New Search
Back to Search Results
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
-
-