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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Regulation Description Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Definition For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Physical State System contains acvetabular screws, acetabular shell, constrained UHMWPE acetabular liner doped with an additive, a femoral ball, and a metallic femoral stem.
Technical Method This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. The liner constrains the head such that it prevent axial dislocation. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene containing an additive such as a-tocopherol articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The shell and stem can be attached to the bone by either cemented, pressfit, or biological fixation.
Target Area Hip
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePBI
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type 510(k)
Regulation Number 888.3310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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