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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 11-307
ASTM  F2385-15 (Reapproved 2019)
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs.

1.2 This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head.

1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly addressed.

1.4 This practice will focus on computer assisted computational methodologies for measuring relative displacements over time but not to the exclusion of other methodologies.

1.5 This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method.

1.6 It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals.

1.7 It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative.

1.8 This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation.
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
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 JDI
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3358 Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 LPH
§888.3358 Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 OQG
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 John Goode
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.