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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.
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
PMA NumberP830055
Supplement NumberS121
Date Received07/18/2011
Decision Date02/09/2012
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 the addition of mobile bearing attune cr (cruciate retaining) rp (rotating platform) tibial bases and tibial inserts for use with previously cleared femoral and patellar components. The device, as modified, will be marketed under the trade name attune rotating platform (rp) total knee system and is indicated for use in total knee replacement in patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.