Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

040

Date of Entry 08/14/2015 

FR Recognition Number

11-294

Standard

ASTM F1357 -14 (Reapproved 2019) Standard Specification for Articulating Total Wrist Implants

Scope/Abstract

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.

Extent of Recognition

Complete standard

Rationale for Recognition

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

Public Law, CFR Citation(s) and Procode(s)*

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 Technical Contact

 John Goode

  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/

  301-796-6407

  john.goode@fda.hhs.gov

Standards Development Organization

ASTM ASTM International http://www.astm.org/

FDA Specialty Task Group (STG)

Orthopedic

*These are provided as examples and others may be applicable.