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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 11-266
Standard
ASTM F2665-09 (Reapproved 2014)
Standard Specification for Total Ankle Replacement Prosthesis
Scope/Abstract
1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1)2 of plantar flexion, as determined by non-clinical testing.

1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to in vivo performance of the prosthesis are defined.

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
§888.3120 Prosthesis, Ankle, Cemented, Non-Constrained Class 3 KXC
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3100 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite Class 2 KMD
Unclassified Prosthesis, Ankle, Uncemented, Non-Constrained Class 3 NTG
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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