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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 8-427
Standard
ASTM F1185-03 (Reapproved 2014)
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Scope/Abstract
1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.)

1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6) .

1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth.

1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.)

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
§888.3670 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
§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 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 MEH
§888.3045 Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class 2 OIS
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP
Relevant FDA Guidance and/or Supportive Publications
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants, (March 10, 1995; revised February 20, 1997).

Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA, (February 7, 2002; revised June 2, 2003).
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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