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, hemi-, femoral, metal
Regulation Description
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWL
Premarket Review
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3360
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
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)]
11-339 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) ]
11-344 ASTM F2580-18
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
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
11-385 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)]
11-395 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
Guidance Document
Non-clinical Information for Femoral Stem Prostheses
Third Party Review
Not Third Party Eligible
-
-