This guide aims to provide guidance for a range of various assessments and evaluations to aid in preclinical research and device development of various UHMWPE components in orthopedic and spinal devices used for the repair of musculoskeletal disorders.

This guide includes brief descriptions of various assessments, representative data, processing conditions, and intended use or uses, as well as the qualitative and quantitative analyses of the UHMWPE powder to a finished product component.

The user is encouraged to use appropriate ASTM International and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE materials, device components, or devices before assessment of an in vivo model.

Assessments of UHMWPE should be performed in accordance with the provisions of 21 CFR 58 where feasible.

Studies to support investigational device exemption (IDE), premarket approval (PMA), or 510K submissions should conform to appropriate Food and Drug Administration (FDA) guidelines for the development of medical devices.

Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on UHMWPE components are not necessarily predictive of human results and should be, therefore, interpreted cautiously with respect to potential applicability to human conditions. Referenced UHMWPE publications can be found in the References section at the end of this guide for further review.

TABLE 1 UHMWPE Fabricated Forms and Conditions

1. Scope

1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.

1.2 This guide includes a description and rationale of assessments for the various UHMWPE types and processing conditions. Assessment testing based on physical, chemical, biocompatibility, mechanical, and preclinical analyses are briefly described and referenced. The user should refer to specific test methods for additional details.

1.3 This guide does not attempt to define all of the assessment methods associated with UHMWPE components in orthopedic and spinal devices.

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 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 and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

D638 Test Method for Tensile Properties of Plastics

D695 Test Method for Compressive Properties of Rigid Plastics

D883 Terminology Relating to Plastics

D2765 Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics

D4020 Specification for Ultra-High-Molecular-Weight Polyethylene Molding and Extrusion Materials

E647 Test Method for Measurement of Fatigue Crack Growth Rates

F619 Practice for Extraction of Medical Plastics

F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F756 Practice for Assessment of Hemolytic Properties of Materials

F763 Practice for Short-Term Screening of Implant Materials

F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices

F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

F2025 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants

F2183 Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

F2214 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

F2381 Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

F2625 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

F2695 Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

Keywords

musculoskeletal joint replacement; orthopedic device; spinal device; UHMWPE; ultra-high molecular weight polyethylene; Musculoskeletal system; Orthopaedic medical devices; Orthopaedic spinal devices; Ultra-high molecular-weight polyethylene (UHMWPE);

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Citing ASTM Standards

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