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

Premarket Approval (PMA)

  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Applicant
DEPUY, INC.
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP830055
Supplement NumberS139
Date Received09/26/2013
Decision Date10/29/2013
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE LABELING (SURGICAL TECHNIQUE) THAT ADD OR STRENGTHEN AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF THE DEVICE. ADDITIONAL INSTRUCTIONS ON THE USE OF THE ATTUNE KNEE SYSTEM BALANCED SIZER ARE BEING ADDED TO THE EXISTING SURGICAL TECHNIQUE BASED ON CLINICAL EXPERIENCE GAINED BY SURGEONS.
-
-