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Cement Restrictor
Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.
Details
Device typePolymer orthopaedic cement restrictor, non-bioabsorbable: A non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application.
FDA categoryProsthesis, Hip, Cement Restrictor
Device ID08031497001579
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Outer Diameter13 Millimeter