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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

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 Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
CDRH Office and Division associated with recognized standards:
Devices Affected:
Calcium Phosphate Coated Orthopedic Arthroplasty and Dental Implants.
Processes Affected:
510(K), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
Unclassified Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 MRA
Unclassified Prosthesis, Intervertebral Disc Class 3 MJO
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§888.3040 Pin, Fixation, Threaded Class 2 JDW
§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
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate Class 2 MEH
§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
§888.3535 Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3690 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 HSD
§888.3730 Prosthesis, Toe, Hemi-, Phalangeal Class 2 KWD
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
FDA Technical Contact:
 Peter Allen
  10903 New Hampshire Building 66, Room 1512
  Silver Spring MD 20993
  email: peter.allen@fda.hhs.gov