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ASTM F2083-07

(Specification)

Standard Specification for Total Knee Prosthesis

Standard Specification for Total Knee Prosthesis

SCOPE
1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110 of flexion to high flexion. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F 1672.
1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

General Information

Status
Historical
Publication Date
31-Jul-2007
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F2083-06b - Standard Specification for Total Knee Prosthesis
Effective Date
01-Aug-2007
Replaced By
ASTM F2083-08 - Standard Specification for Total Knee Prosthesis
Effective Date
01-Jul-2008
Referred By
ASTM F1800-19e1 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Effective Date
01-Aug-2007
Referred By
ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
Effective Date
01-Aug-2007
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Aug-2007
Referred By
ASTM F2722-21 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
Effective Date
01-Aug-2007
Referred By
ASTM F3495-23 - Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
Effective Date
01-Aug-2007
Referred By
ASTM F3140-23 - Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
Effective Date
01-Aug-2007
Referred By
ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
Effective Date
01-Aug-2007
Referred By
ASTM F2777-23 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
Effective Date
01-Aug-2007

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ASTM F2083-07 - Standard Specification for Total Knee ProsthesisASTM F2083-07 - Standard Specification for Total Knee Prosthesis
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ASTM F2083-07 - Standard Specification for Total Knee Prosthesis
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 2083 – 07
Standard Specification for
1
Total Knee Prosthesis
This standard is issued under the fixed designation F 2083; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.1 This specification covers total knee replacement (TKR)
tions (UNS R30605)
prostheses used to provide functioning articulation by employ-
F 136 Specification for Wrought Titanium-6Aluminum-
ing femoral and tibial components, allowing a minimum of
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
110° of flexion to high flexion.Although a patellar component
Implant Applications (UNS R56401)
may be considered an integral part of a TKR, the detailed
F 138 Specification for Wrought 18Chromium-14Nickel-
description of this component is excluded here since it is
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
provided in Specification F 1672.
Implants (UNS S31673)
1.2 Included within the scope of this specification are
F 451 Specification for Acrylic Bone Cement
replaceablecomponentsofmodulardesigns,forexample,tibial
F 562 Specification for Wrought 35Cobalt-35Nickel-
articulating surfaces and all components labeled for or capable
20Chromium-10Molybdenum Alloy for Surgical Implant
of being used with cement, regardless of whether the same
Applications (UNS R30035)
components can also be used without cement. This includes
F 563 Specification for Wrought Cobalt-20Nickel-
primary and revision prostheses and also covers fixed and
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
mobile bearing knee designs.
3
for Surgical Implant Applications (UNS R30563)
1.3 This specification is intended to provide basic descrip-
F 648 Specification for Ultra-High-Molecular-Weight Poly-
tions of material and prosthesis geometry. Additionally, those
ethylene Powder and Fabricated Form for Surgical Im-
characteristics determined to be important to in vivo perfor-
plants
mance of the prosthesis are defined.
F 732 Test Method forWearTesting of Polymeric Materials
1.4 Excluded from the scope are hemiarthroplasty devices
Used in Total Joint Prostheses
that replace only the femoral or tibial surface, but not both;
F 745 Specification for 18Chromium-12.5Nickel-
unicompartmental designs, which replace the articulating sur-
2.5Molybdenum Stainless Steel for Cast and Solution-
faces of only one condyle; and patellofemoral prostheses.Also
Annealed Surgical Implant Applications
excluded are devices designed for custom applications.
F 746 Test Method for Pitting or Crevice Corrosion of
2. Referenced Documents Metallic Surgical Implant Materials
2
F 748 Practice for Selecting Generic Biological Test Meth-
2.1 ASTM Standards:
ods for Materials and Devices
F67 Specification for Unalloyed Titanium, for Surgical
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
Implant Applications (UNS R50250, UNS R50400, UNS
Alloy Forgings for Surgical Implants (UNS R31537,
R50550, UNS R50700)
R31538, R31539)
F75 SpecificationforCobalt-28Chromium-6Molybdenum
F 981 Practice for Assessment of Compatibility of Bioma-
Alloy Castings and Casting Alloy for Surgical Implants
terials for Surgical Implants with Respect to Effect of
(UNS R30075)
Materials on Muscle and Bone
F86 Practice for Surface Preparation and Marking of Me-
F 983 Practice for Permanent Marking of Orthopaedic Im-
tallic Surgical Implants
plant Components
F 1044 Test Method for Shear Testing of Calcium Phos-
phate Coatings and Metallic Coatings
1
This specification is under the jurisdiction of ASTM Committee F04 on
F 1108 Specification for Titanium-6Aluminum-4Vanadium
Medical and Surgical Materials and Devices and is the direct responsibility of
Alloy Castings for Surgical Implants (UNS R56406)
Subcommittee F04.22 on Arthroplasty.
F 1147 Test Method for Tension Testing of Calcium Phos-
Current edition approved Aug. 1, 2007. Published September 2007. Originally
approved in 2001. Last previous edition approved in 2006 as F 2083 – 06b.
phate and Metallic Coatings
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
3
the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2083–07
F 1160 Test Method for Shear and Bending Fatigue Testing 3.1.7 patella component, n—bearing member fixed to the
of
...

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4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
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4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.
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1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
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1.4 This test method applies to bearing components manufactured from UHMWPE.  
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
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1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
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1.5 The values stated in SI units are to be regarded as the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off