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The PIPELINE 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, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. - Acute traumatic fracture of the femoral head or neck. - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application. The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K130353) to the subject hip system: - A size 1 femoral stem; - Hip stems (all sizes, 1-12) with the option of 3 tantalum beads, to allow the surgeon to perform radiostereometric analysis(RSA) to measure implant migration; and - Optional acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells. These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K12802 and K131237 and as the PBP Total Hip System in 510(k) #K122158.