ASTM F2091-15
Standard Specification for Acetabular Prostheses

Standard No.

ASTM F2091-15

Release Date

2015

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2091-15

Scope

1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.

1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined.

1.3 Acetabular prostheses included within the scope of this specification are intended for fixation by press-fit between the prosthesis and host bone, the use of bone cement, the use of bone screws or similar means of mechanical fixation, or through biological fixation of host bone and/or soft connective tissue into a porous surface.

1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification.

1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.

ASTM F2091-15 Referenced Document

• ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
• ASTM F1108 Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
• ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
• ASTM F1160 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F1377 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075)
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• ASTM F1714 Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• ASTM F1820 Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
• ASTM F1978 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber^TM Abraser
• ASTM F2033 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
• ASTM F2565 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• ASTM F2582 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
• ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
• ASTM F601 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• ASTM F603 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
• ASTM F629 Standard Practice for Radiography of Cast Metallic Surgical Implants
• ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F746 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 14242-1 Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test AMENDMENT 1
• ISO 14242-2 Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
• ISO 14242-3 Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test AMENDMENT 1
• ISO 21535 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
• ISO 6474-1 Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina
• ISO 6474-2 Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
• ISO 9001 Quality management systems - Requirements [Spanish version]

ASTM F2091-15 history

• 2015 ASTM F2091-15 Standard Specification for Acetabular Prostheses
• 2001 ASTM F2091-01(2012) Standard Specification for Acetabular Prostheses
• 2001 ASTM F2091-01(2006) Standard Specification for Acetabular Prostheses
• 2001 ASTM F2091-01 Standard Specification for Acetabular Prostheses