• 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 | Inspections

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameknee implant - uncemented
ApplicantDEPUY, INC.
PMA NumberP910016
Supplement NumberS009
Date Received11/25/1997
Decision Date01/15/1998
Product Code
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the name of the unicompartmental configuration of the new jersey lcs(r) total knee system. This device will now be marketed under the trade name unicompartmental configuraiton ofthe lcs(r) total knee system and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (nidjd) or its composite diagnoses of osteoarthritis or post-traumatic arthritis.