Product Classification

• Device: prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
• Regulation Description: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MBF
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3670
• 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
• 8-427 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
• 8-495 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
• 8-516 ISO 13779-4 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
• 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
• 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)]
• 8-593 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
• 11-330 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