Device Dossier

Biomet Modular Primary I-beam tibial stem 40MM with screw - Uncoated knee tibia prosthesis, metallic

Device Dossier for Biomet Modular Primary I-beam tibial stem 40MM with screw - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis,…

Intended purpose

Titanium alloy modular I-beam stem component for use with modular tibial plate. Intended for cemented use as one component of a total knee joint prosthesis. Indications for use: severely painful and disabled joints resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or both of the compartments are involved; failure of a previous joint replacement procedure; correction of varus, valgus or post-traumatic deformity; unsuccessful osteotomy or arthrodesis.

Functional description

40 MM titanium alloy primary modular I-beam tibial stem component using combination of Morse taper and screw fixation to help maintain a solid connection between stem and plate. Packaged with screw; intended for cemented use

TGA Public Summary