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Device
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
MBH
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3565
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
8-195 ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
8-380 ASTM F1160-14 (Reapproved 2017)e1
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
8-427 ASTM F1185-03 (Reapproved 2014)
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
8-493 ISO 13779-2 Third edition 2018-12
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
8-516 ISO 13779-4 Second edition 2018-12
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
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
8-579 ISO 13779-3 Second Edition 2018-12
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
8-585 ASTM F1377-21
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
Implants for surgery - Hydroxyapatite - Part 6: 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
11-232 ISO 7207-1 Third edition 2007-02-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
11-281 ASTM F1672-14 (Reapproved 2019)
Standard Specification for Resurfacing Patellar Prosthesis
11-306 ASTM F1814-15
Standard Guide for Evaluating Modular Hip and Knee Joint Components
11-308 ASTM F3161-16
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
11-311 ISO 14243-2 Third edition 2016-09-01
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
11-335 ASTM F3141-17a
Standard Guide for Total Knee Replacement Loading Profiles
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-361 ISO 14243-5 First edition 2019-05
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
11-364 ISO 14243-1 Second edition 2009-11-15
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-365 ASTM F1800-19 e1
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
11-367 ISO 14243-3 Second edition 2014-11-01
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-368 ASTM F3334-19
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
11-370 ISO 14879-1 Second edition 2020-07
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
11-373 ASTM F1223-20
Standard Test Method for Determination of Total Knee Replacement Constraint
11-374 ISO 7207-2 Second edition 2011-07-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
11-377 ASTM F2083-21
Standard Specification for Knee Replacement Prosthesis
11-395 ASTM F1814-22
Standard Guide for Evaluating Modular Hip and Knee Joint Components
11-397 ASTM F3210-22e1
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
11-400 ISO 21536 Third edition 2023-07
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
Third Party Review
Not Third Party Eligible
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