Device typeFixed-bearing total ankle prosthesis: A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.
FDA categoryPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Device ID00889797069663
Catalog number33680004
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
SizeSize: 4