Device Dossier
Knee stem
Device Dossier for Knee stem (Knee stem, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
Intended purpose
A component designed to attach to the stem of the femoral or tibial component to provide additional stability. A knee stem intended for use in total knee replacement. Indications: Revision of previous unsuccessful knee replacement or other procedure. The following indications apply in complex primary and/or revision Total Knee Arthroplasty: Ligamentous instability requiring implant bearing surface geometries with increased constraint; Absent or non-functioning posterior cruciate ligament; Severe anteroposterior instability of the knee joint; Severe instability of the knee secondary to compromised collateral ligament integrity or function.