• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 8-457
Standard
ISO 13175-3 First edition 2012-10-01
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
Scope/Abstract
This 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.
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
§882.5320 Filler, Bone Void, Alterable Compound For Cranioplasty Class 2 PJM
§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*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device. Issued on June 2, 2003.
FDA Technical Contacts
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Peter Allen
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6402
  peter.allen@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
-
-