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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.
PMA NumberP960047
Supplement NumberS001
Date Received02/27/1998
Decision Date04/02/1998
Docket Number N
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: 1) the introduction of 10 additional sizes to the pma-approved constrained acetabular insert product line; 2) a minor modification in the packaging scheme applicable to the pma-approved constrained acetabular insert product line; 3) manufacturing tolerance changes to the pma-approved constrained acetabular insert product line; and 4) an inspection code modification on the engineering drawing for the pma-approved constrained acetabular insert product line. The device, as modified, will be marketed under the trade name osteonics constrained acetabular insert and is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.