Premarket Approval (PMA)

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 Name: LCS TOTAL KNEE SYSTEM
• Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Generic Name: prosthesis, knee, patellofemorotibial, semi-cons
• Applicant: DEPUY ORTHOPAEDICS, INC.
• PMA Number: P830055
• Supplement Number: S127
• Date Received: 08/16/2012
• Decision Date: 11/19/2012
• Product Code: NJL [ Registered Establishments with NJL ]
• Advisory Committee: Orthopedic
• Supplement Type: real-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 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 new inserts 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.