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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceLCS UNI KNEE SYSTEM
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, IN 46581-0988
PMA NumberP910016
Supplement NumberS015
Date Received11/10/2005
Decision Date12/12/2005
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN QUALITY CONTROLS TO THE LCS PRESERVATION UNI MOBILE BEARING INSERTS APPROVED IN P910016/S012. THE CHANGES INCLUDE MODIFICATIONS TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
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