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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.
 
Trade NameLCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS067
Date Received10/18/1999
Decision Date11/22/1999
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for several sizes of newly developed trochlear groove implants to be used in conjunction with currently marketed patellar componenets of the lcs total knee system for the purpose of resurfacing the patellofemoral joint. This device is indicated for patients with isolated patellofemoral osteoarthritis, a history of patellar dislocation or patellar fracture, or a failed previous surgery where pain, deformity or dysfunction persist. The trochlear implants are intended for cemented use only.
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