Device Dossier

Zimmer Segmental System, Trabecular Metal™ Stem Collar - Knee stem

Device Dossier for Zimmer Segmental System, Trabecular Metal™ Stem Collar - Knee stem (Knee stem, Class III, sponsor Zimmer Biomet). ARTG record,…

Intended purpose

The TM Stem Collar is a part of the Zimmer Segmental System and is indicated for Moderate to severe knee instability; Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia; Valgus, varus or flexion deformities; The salvage of previously failed surgical attempts.

Functional description

Segmental Trabecular Metal Stem Collars are made of Trabecular Metal (porous tantalum) and are offered in multiple sizes to fit the patient’s bone, maximizing bone contact, promoting extracortical loading and facilitating bone ingrowth. The pore size and high volume porosity of Trabecular Metal Material used in the collars supports vascularization and rapid, secure soft tissue ingrowth. They are compatible with all Segmental system stems and may be used cemented or uncemented against the bone.

TGA Public Summary