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, wrist, 3 part metal-plastic-metal articulation, semi-constrained
Regulation Description
Wrist joint metal/polymer semi-constrained cemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
JWJ
Premarket Review
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3800
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
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)]
8-403 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
8-495 ISO 5834-3 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
8-496 ISO 5834-4 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
8-497 ISO 5834-5 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
8-501 ISO 5834-1 Fourth edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
8-514 ISO 5834-2 Fifth edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
8-572 ASTM F2565-21
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
8-573 ASTM F2695-12(2020)
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
8-577 ISO 13179-1 Second Edition 2021-09
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
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
11-294 ASTM F1357-14 (Reapproved 2019)
Standard Specification for Articulating Total Wrist Implants
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
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
11-399 ASTM F1357-23
Standard Specification for Articulating Total Wrist Implants
Third Party Review
Not Third Party Eligible
-
-