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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 11-344
Standard
ASTM F2580-18
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
Scope/Abstract
1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.

1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.

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.
Transition Period
FDA recognition of ASTM F2580-13[Rec# 11-295] will be superseded by recognition of ASTM F2580-18 [Rec# 11-344]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-295] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 11-295] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3360 Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 JDG
§888.3360 Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 KWL
§888.3360 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 LWJ
§888.3360 Prosthesis, Upper Femoral Class 2 JDD
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Class 2 MBL
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class 2 PBI
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented Class 3 LPF
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, September 17, 2007
FDA Technical Contact
 John Goode
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-6407
  john.goode@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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