| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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047
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Date of Entry 08/21/2017
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FR Recognition Number
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8-195
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| Standard | |
ASTM F2024-10 (Reapproved 2016)
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
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Scope/Abstract1.1 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. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3640 |
Implant, Endosseous, Root-Form
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Class 2
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DZE
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| §888.3040 |
Pin, Fixation, Threaded
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Class 2
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JDW
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| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation
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Class 2
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MNH
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| §888.3070 |
Orthosis, Spinal Pedicle Fixation
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Class 2
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MNI
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| §888.3070 |
Thoracolumbosacral Pedicle Screw System
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Class 2
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NKB
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| §888.3070 |
Posterior Metal/Polymer Spinal System, Fusion
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Class 2
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NQP
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| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
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Class 3
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KWA
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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Class 2
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MEH
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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Class 2
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LPH
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| §888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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Class 2
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MBL
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| §888.3358 |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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Class 2
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OQG
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| §888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
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Class 2
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NJD
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| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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Class 2
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MBH
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| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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Class 2
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KWT
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| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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Class 2
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KWS
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| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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MBF
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| §888.3690 |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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Class 2
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HSD
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| §888.3730 |
Prosthesis, Toe, Hemi-, Phalangeal
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Class 2
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KWD
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| N/A |
Prosthesis, Intervertebral Disc |
Class 3
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MJO
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| N/A |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3
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MRA
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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
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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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. |
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