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Device
prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
HSN
Premarket Review
Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3110
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
8-423 ASTM F2565-13
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
8-424 ASTM F2695-12
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
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
11-266 ASTM F2665-09 (Reapproved 2014)
Standard Specification for Total Ankle Replacement Prosthesis
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-362 ISO 22622 First edition 2019-07
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
11-386 ASTM F2665-21
Standard Specification for Total Ankle Replacement Prosthesis
Third Party Review
Not Third Party Eligible
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