• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameS-ROM POLY-DIAL CONSTRAINED LINER
Classification Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDEPUY, A JOHNSON & JOHNSON CO.
PMA NumberP960054
Date Received12/26/1996
Decision Date06/19/1997
Reclassified Date 05/30/2002
Product Code
KWZ[ Registered Establishments with KWZ ]
Docket Number 97M-0416
Notice Date 10/07/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the johnson and johnson's s-rom poly-dial constrained acetabular liner. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Supplements: S002 S003 S004 
-
-