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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOSTEONICS CONSTRAINED ACETABULAR INSERT
ApplicantHowmedica Osteonics Corp.
59 Rte. 17 S.
Allendale, NJ 07401
PMA NumberP960047
Supplement NumberS001
Date Received02/27/1998
Decision Date04/02/1998
Reclassified Date04/30/2002
Docket Number N
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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