ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants

The standard “ASTM F1357-23 Standard specification for articulating total wrist implants,” developed by the American Society for Testing and Materials (ASTM), describes total wrist implants used to provide functional articulation using radial and carpal components. This specification excludes implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants (with or without grommets), and devices used for special applications.

In this standard, the classification is made as follows:

• Constrained: A constrained joint prosthesis is used for joint replacement and prevents displacement of the prosthesis in more than one anatomic plane and consists of a single, flexible, cross-joint component or multiple components connected or in close proximity to each other.
• Semi-constrained: A semi-constrained joint prosthesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes through the geometry of the articular surfaces. It has no attachments across the joint.
• Unconstrained: An unconstrained joint prosthesis is used for partial or total joint replacement and minimally restricts the movement of the prosthesis in one or more planes. Its components have no connections across the joint.

It is understood that the choice of materials is a necessary but not sufficient guarantee of the functionality of the device made from them. All devices complying with this standard are manufactured from materials having sufficient mechanical strength and durability, corrosion resistance and biocompatibility.

Examples of materials successfully used to manufacture wrist replacement components include ASTM F67-13, ASTM F75-23, ASTM F90-14, ASTM F136-13, ASTM F562-02, ASTM F799-02, ASTM F1108-04, ASTM F1472-23, ASTM F1537-20, ISO 5832-2, ISO 5832-3, ISO 5832-4, ISO 5832-5, or ISO 5832-12 standards. Polymeric bearing components are manufactured from ultra-high molecular weight polyethylene as specified in ASTM F648-21 or ISO 5834-2 standards. Not all of these materials may possess sufficient mechanical strength for critically high-stress components or joint surfaces.

For biocompatibility, devices made from materials with limited or no history of successful use for orthopedic implant applications should be determined to demonstrate acceptable biological response when tested in accordance with ASTM F748-16 or ASTM F981-04 or ISO 10993-1. Although no known surgical implant material has been demonstrated to be completely free of adverse reactions in the human body, long-term clinical experience has shown that an acceptable level of biological response can be expected if materials listed in this standard are used. However, the listed specifications cover raw materials and do not cover finished medical devices where the design and manufacturing process of the device may affect the biological response. Therefore, for devices made from listed materials, biocompatibility should be verified in accordance with ASTM F748-16 or ASTM F981-04 or ISO 10993-1 unless it can be justified that the design and processing will not affect the biocompatibility of the final, sterilized device.

In terms of polymeric component oxidation resistance, polymer components may be subject to deterioration in mechanical or wear performance due to oxidation and may need to be aged prior to subsequent mechanical testing following the ASTM F2003-02 standard.

When required for metallic implants, fluorescent penetrant testing should be performed in accordance with ASTM F601-23.

When casting is required for metallic implants, radiography should be performed in accordance with ASTM F629-20.

With respect to corrosion resistance, materials with limited or no history of successful use for orthopedic implant applications should be determined to exhibit corrosion resistance equal to or better than one of the materials listed in this standard when tested in accordance with ASTM F2129-01 and ASTM F3306-19. The design and manufacturing process of the device can affect corrosion resistance, therefore, testing should be performed on the final devices in their final finished form. If all processing steps, including sterilization and preconditioning, are comparable to the finished device, substitute test materials may be used for testing with sufficient justification. If a material has less corrosion resistance than one of the materials listed when tested in accordance with ASTM F2129-01 and ASTM F3306-19, its use should be justified.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, our organization also provides testing services defined in the "ASTM F1357-23 Standard specification for jointed total wrist implants" standard with its trained and expert staff and advanced technological equipment.