|Trade Name||STELKAST SURPASS ACETABULAR SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Generic Name||total hip system,ceramic articulation|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for implementation of new software to the manufacturing line to allow polished inserts to be reworked, following inspection, in one of the two inner sphere polishing stations, while the other station continues to be used for initial production.