FDA.reportPublic FDA data

Polymer orthopaedic cement restrictor, bioabsorbable

Definition
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.
GUDID devices
32
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03760177040472CEMSTOPTEKNIMEDDiameter 082015-10-16
03760177040489CEMSTOPTEKNIMEDDiameter 102015-10-16
03760177040496CEMSTOPTEKNIMEDDiameter 122015-10-16
03760177040502CEMSTOPTEKNIMEDDiameter 142015-10-16
03760177040519CEMSTOPTEKNIMEDDiameter 162015-10-16
03760177040526CEMSTOPTEKNIMEDDiameter 182015-10-16
03760177043961CLEARCUTTEKNIMEDDiameter 082015-10-16
03760177043978CLEARCUTTEKNIMEDDiameter 102015-10-16
03760177043985CLEARCUTTEKNIMEDDiameter 122015-10-16
03760177043992CLEARCUTTEKNIMEDDiameter 142015-10-16
03760177044005CLEARCUTTEKNIMEDDiameter 162015-10-16
03760177044012CLEARCUTTEKNIMEDDiameter 182015-10-16
10603295174608BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-20-0002015-09-24
03760177041295MectaPlugTEKNIMEDDiameter 082015-10-16
03760177041301MectaPlugTEKNIMEDDiameter 102015-10-16
03760177041318MectaPlugTEKNIMEDDiameter 122015-10-16
03760177041325MectaPlugTEKNIMEDDiameter 162015-10-16
03760177041332MECTAPLUGTEKNIMEDDiameter 182015-10-16
03760177044029MectaPlugTEKNIMEDDiameter 142015-10-16
03760177046542CLEARCUTTEKNIMEDDiameter 082020-11-25
03760177046573CLEARCUTTEKNIMEDDiameter 102020-11-25
03760177046603CLEARCUTTEKNIMEDDiameter 122020-11-25
03760177046634CLEARCUTTEKNIMEDDiameter 142020-11-25
03760177046665CLEARCUTTEKNIMEDDiameter 162020-11-25
03760177046696CLEARCUTTEKNIMEDDiameter 182020-11-25
03760177046535CLEARCUTTEKNIMEDDiameter 062020-09-24
10603295174547BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-08-0002015-09-24
10603295174554BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-10-0002015-09-24
10603295174561BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-12-0002015-09-24
10603295174578BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-14-0002015-09-24
10603295174585BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-16-0002015-09-24
10603295174592BIOSTOPDEPUY ORTHOPAEDICS, INC.5463-18-0002015-09-24