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Device
prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description
Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWS
Premarket Review
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3660
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
8-368 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
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
11-330 ASTM F2028-17
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
11-334 ASTM F1829-17
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-360 ASTM F1378-18e1
Standard Specification for Shoulder 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
11-405 ASTM F1829-23
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Third Party Review
Not Third Party Eligible
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