Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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11-266
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Standard | |
ASTM F2665-09 (Reapproved 2014) Standard Specification for Total Ankle Replacement Prosthesis |
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Scope/Abstract1.1 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. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ASTM F2665-09 (Reapproved 2014) [Rec# 11-266] will be superseded by recognition of ASTM F2665-21 [Rec# 11-386]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-266] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 11-266] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§888.3100 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KMD |
§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSN |
§888.3120 |
Prosthesis, Ankle, Cemented, Non-Constrained |
Class 3 |
KXC |
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Unclassified |
Prosthesis, Ankle, Uncemented, Non-Constrained |
Class 3 |
NTG |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |