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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-constrained, metal/polymer, mobile bearing
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP830055
Supplement NumberS127
Date Received08/16/2012
Decision Date11/19/2012
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of mobile bearing attune ps rp tibial inserts that are modifications to the previously approved lcs complete/pfc sigma rp/attune rp tibial inserts, and are intended to be used with the cleared attune total knee system femoral, patella, and components. The supplement also requests the addition of a 9mm tibial insert thickness for all sizes (i - i 0) of attune cr rp tibial inserts. The newinserts are manufactured from the antioxidant polyethylene material (aox). The device, as modified, will be marketed under the trade name attune 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.