Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-245: ASTM F384-12, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. (Orthopaedics)

Date of Standard: 2012. 
Address of Standards Organization:
  ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Nail/screw/blade/plate combination fixation devices
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard.

Standard covers basic definitions and test methods for the characterization and comparison of angled fixation devices. Although the standard primarily deals with plate/screw combinations, it is also applicable to some intramedullary nail/screw combination. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3020 Rod, Fixation, Intramedullary And Accessories Class 2 HSB
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 LXT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class 2 KTW
§888.3030 Device, Fixation, Proximal Femoral, Implant Class 2 JDO
§888.3030 Nail, Fixation, Bone Class 2 JDS
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Michael Kasser
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1576
  Silver Spring MD 20993
  301/796-6946
  Email: michael.kasser@fda.hhs.gov
-
-