| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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043
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Date of Entry 06/27/2016
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FR Recognition Number
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8-427
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| Standard | |
ASTM F1185-03 (Reapproved 2014)
Standard Specification for Composition of Hydroxylapatite for Surgical Implants |
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Scope/Abstract1.1 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.) |
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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 |
| §888.3045 |
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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Class 2
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MBP
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| §888.3045 |
Filler, Bone Void, Calcium Compound
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Class 2
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MQV
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| §888.3045 |
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
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Class 2
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OIS
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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Class 2
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LZO
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| §888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
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Class 2
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MAY
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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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| §888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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Class 2
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OQI
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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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| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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MBF
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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).
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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