ASTM International - ASTM F1357-99(2009)
Standard Specification for Articulating Total Wrist Implants
|Publication Date:||15 June 2009|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial carpal components.
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one piece elastomeric implants (with or without grommets), and those devices used for custom applications.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or... View More
This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or porous coated surfaces, one-piece elastomeric implants, and those used for custom applications. Implants covered by this specification are of the constrained, partially constrained, or unconstrained joint prosthesis type. The implants shall be manufactured from biocompatible materials made of unalloyed titanium, cobalt-28chromium-6m