ASTM F1357 -14

Standard Organization:

ASTM F1357 -14
Standard Specification for Articulating Total Wrist Implants

Recognition Date2015-08-14
Recognition List040
Recognition Number11-294
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial and 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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3800 Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained Class 2 JWI
§888.3800 Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Class 2 JWJ
§888.3800 Prosthesis, Wrist, Semi-Constrained Class 2 KWM
§888.3790 Prosthesis, Wrist, Constrained, Metal Class 3 KYN
§888.3780 Prosthesis, Wrist, Constrained, Polymer Class 2 KIG

FDA Guidance:

There is no relevant guidance developed at this time.

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