Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 8-195: ASTM F2024-10, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings. (Materials)
Date of Standard: 2010. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Calcium Phosphate Coated Orthopedic Arthroplasty and Dental Implants. |
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| Processes Affected: |
| 510(K), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| International, Horizontal |
| Extent of Recognition: |
Complete Standard.
The standard does not recommend a sample number. FDA recommends a sample number of 3 spectra for the initial powder and 3 spectra for the final (i.e., sterilized) coating.
The standard does not provide the percentage of crystallinity for the final coating. Additional calculations are therefore requested. The percentage of crystallinity in terms of all crystalline phases is defined by Prevey* as the sum of the weight fraction of all crystalline phases excluding the amorphous phase, which is roughly the sum of WHA and Wother crystalline CaP impurities (in percentage), as determined in ASTM F2024-10 noting the impurity phases measured. The percentage of crystallinity in terms of HA phase only is defined as the weight fraction of crystalline HA phase, which is same as the WHA (in percentage) per ASTM F2024-10.
By using the example calculations from ASTM F2024-10, the definition can be simplified as the following:
XC% = WHA + W other crystalline CaP impurities = 60.7% +1.0% + 5.8% = 67.5%
XC HA% = WHA (in percentage) = 60.7%
In addition to providing the weight percentages per ASTM F2024 of the starting powders and the final coating, FDA recommends providing the XC% and the XC HA% of the final coating.
*Prevey, P.S., and Rothwell, R.J., ?X-ray Diffraction Characterization of Percent Crystallinity and Contaminants in Plasma-Sprayed Hydroxylapatite Coatings,? Characterization and Performance of Calcium Phosphate Coatings for Implants, ASTM STP 1196, Emanuel Horowitz and Jack E. Parr, eds., American Society for Testing and Materials, Philadelphia, PA, 1994, p. 63. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
Class 3 |
MRA |
| Unclassified |
Prosthesis, Intervertebral Disc |
Class 3 |
MJO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3640 |
Implant, Endosseous, Root-Form |
Class 2 |
DZE |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3040 |
Pin, Fixation, Threaded |
Class 2 |
JDW |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation |
Class 2 |
MNI |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Class 3 |
NKB |
| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation |
Class 2 |
MNH |
| §888.3070 |
Posterior Metal/Polymer Spinal System, Fusion |
Class 2 |
NQP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3330 |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
Class 3 |
KWA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
Class 2 |
MEH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3535 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Class 2 |
NJD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3565 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Class 2 |
MBH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Class 2 |
KWT |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Class 2 |
KWS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3690 |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Class 2 |
HSD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3730 |
Prosthesis, Toe, Hemi-, Phalangeal |
Class 2 |
KWD |
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| Relevant Guidance: |
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, March 10, 1995 (revised 2/20/97)
This guidance provides for more details on methods and recommended sample number for the calcium phosphate coating characterization. Coated coupon samples that are subject to identical manufacturing and processing procedures as the final device, including sterilization, have been acceptable for most coating characterization testing; however, for solubility product and dissolution rate parameters, it is recommended that the coatings be scraped from the actual implants. Regarding the solubility product and dissolution parameters, FDA recommends a sample size of 6 for each of the before and after coating samples. Regarding the solubility product testing, FDA recommends using the NIST method (found in the Certificate of Analysis for the SRM 2910 material at http://ts.nist.gov/srm) or, if using another method, the NIST SRM 2910 or 2910a material as a comparator for the before coating samples. For the dissolution rate testing (e.g., ASTM F1926) FDA recommends using the NIST SRM 2910 or 2910a as a comparator. Per current Orthopedic Joint Devices Branch practices, FDA recommends that the Ca/P ratio be provided for the entire coating via wet chemistry methods. Regarding the Scanning Electron Microscopy (SEM) photos, FDA recommends providing a sample size of 3 for each of the photos provided on the surface and in cross-section
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 |
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| FDA Technical Contact: |
| Peter Allen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Building 66, Room 1512 |
| Silver Spring MD 20993 |
| 301/796-6402 |
| Email: peter.allen@fda.hhs.gov |
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