| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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047
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Date of Entry 08/21/2017
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|
FR Recognition Number
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8-457
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| Standard | |
ISO 13175-3 First edition 2012-10-01
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
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Scope/AbstractThis part of ISO 13175 specifies requirements for monophasic hydroxyapatite bone substitutes, monophasic β-tricalcium phosphate bone substitutes and biphasic hydroxyapatite/β-tricalcium phosphate bone substitutes in the form of blocks or granules.
This part of ISO 13175 is not applicable to cell-seeded bone void fillers, calcium phosphate cements or bone void fillers containing materials other than hydroxyapatite and β-tricalcium phosphate. |
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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 |
| §882.5320 |
Filler, Bone Void, Alterable Compound For Cranioplasty
|
Class 2
|
PJM
|
| §888.3045 |
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
|
Class 2
|
MBP
|
| §888.3045 |
Filler, Bone Void, Calcium Compound
|
Class 2
|
MQV
|
| §888.3045 |
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
|
Class 2
|
OIS
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device. Issued on 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. |
