Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
041
|
Date of Entry 04/04/2016
|
FR Recognition Number
|
8-400
|
Standard | |
ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
|
Scope/Abstract1.1 This test method covers stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates.
1.2 A method to measure void content and intercept length at distinct levels ("Tissue Interface Gradients") through the porous coating thickness is outlined in 9.4. |
|
Extent of Recognition
|
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 |
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Class 2 |
LPH |
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
Class 2 |
MBL |
§888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Class 2 |
OQG |
§888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
§888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 2 |
MBH |
§888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Class 2 |
NJD |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, April 28, 1994
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |
|
|