Details
Device typePolymer orthopaedic cement restrictor, bioabsorbable: A sterile, implantable device that is chemically degraded and absorbed via natural body processes 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 made of bioabsorbable synthetic polymer materials 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 is not intended for spinal indication.
FDA categoryCement Obturator
Device ID03760177046542
Catalog number415-00-080
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Outer Diameter8 Millimeter