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The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: · A severely painful and or disabled joint from osteoarthritis, theumator arthritis, avascular necrosis, or congenital hip dysplasia; · Acute traumatic fracture of the femoral head or neck; · Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The NextStep Arthropedix Total Hip Replacement System includes a family of femoral stems, femoral head components, acetabular UHMWPE liners, acetabular cups (including solid, 3-holed, and the subject multiholed), acetabular hole covers, optional acetabular screws, instruments, and sterilization cases (K161184/K172501). The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases for steam sterilization.