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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acetabular cup orientation system
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Definition The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
Product CodePLW
Regulation Number 888.3350
Device Class 2