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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 8-195
Standard
ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
Scope/Abstract
1.1 This practice is for the determination, by the Reference Intensity Ratio External Standard Method, of the percent by weight of the crystalline phases, hydroxyapatite (HA), beta-(whitlockite) tricalcium phosphate (beta-TCP), and calcium oxide (CaO) in coatings deposited upon metallic substrates by plasma-spraying hydroxyapatite.

1.2 A major component in plasma-sprayed HA coatings other than HA is expected to be amorphous calcium phosphate (ACP). Crystalline components other than HA that may be present include alpha- and beta- (whitlockite) tricalcium phosphates, tetracalcium phosphate (TTCP), calcium oxide, and calcium pyrophosphates. Quantification of the minor crystalline components has proven to be very unreliable due to extreme overlap and confounding of X-ray diffraction peaks. Therefore, this practice addresses the quantification of only HA, beta-TCP, and CaO.

1.3 This practice was developed for plasma-sprayed HA coatings with HA contents of at least 50% of the total coating. It is recognized that the analysis of the crystalline components uses diffraction from regions of the pattern that also includes a small contribution from the amorphous component. However, within the limits of applicability of this practice, the effect of such interference is believed to be negligible.

1.4 The coating analyzed shall be produced and processed under equivalent manufacturing conditions to that on the device of interest.

1.5 This practice requires the use of monochromated copper Kalpha radiation and flat samples.

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
§888.3730 Prosthesis, Toe, Hemi-, Phalangeal Class 2 KWD
§888.3690 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 HSD
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§888.3535 Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§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 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Posterior Metal/Polymer Spinal System, Fusion Class 2 NQP
§888.3070 Thoracolumbosacral Pedicle Screw System Class 2 NKB
§888.3040 Pin, Fixation, Threaded Class 2 JDW
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Unclassified Prosthesis, Intervertebral Disc Class 3 MJO
Relevant FDA Guidance and/or Supportive Publications
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, March 10, 1995 (revised 2/20/97)

FDA Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, April 28, 1994

510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, March 10, 1995 (revised 2/20/97)

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004
FDA Technical Contacts
 Peter Allen
  FDA/OMPT/CDRH/ODE/DOD/JFDB1/
  301-796-6402
  peter.allen@fda.hhs.gov
 Limin Sun
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-7056
  limin.sun@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
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