| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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8-605
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| Standard | |
ASTM F1609-23
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
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Scope/Abstract1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.
1.2 In particulate and monolithic form, the calcium phos-phate materials system has been well characterized regarding biological response (1, 2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.
1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phos-phate dihydrate) coatings, or a coating containing a combina-tion of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering.
1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.
1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms.
1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species.
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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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Transition Period
| FDA recognition of ASTM F1609-08 (Reapproved 2014) [Rec# 8-171] will be superseded by recognition of ASTM F1609-23 [Rec# 8-605]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-171] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-171] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Implantable Medical Devices |
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Relevant FDA Guidance and/or Supportive Publications*
| 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. |
