Device Dossier

S-ROM Noiles NRH Tibial Insert - Rotating hinged total knee prosthesis

Device Dossier for S-ROM Noiles NRH Tibial Insert - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…

Intended purpose

The S-ROM Noiles NRH Tibial Insert is the insert component of the S-ROM NOILES Rotating Hinge Knee system which is indicated for primary or revision cases in patients:- - who have reached skeletal maturity and - for whom the surgeon has decided to resect both cruciate ligaments or whose cruciate ligaments are absent or incompetent and - who exhibit insufficiency of lateral/collateral ligaments and other soft supporting tissue due to the following conditions: Rheumatoid arthritis,osteoarthritis, post-traumatic arthritis, and arthritis secondary to variety of diseases and anomalies, failure of a previous knee reconstruction procedure, trauma.

Functional description

The S-ROM Noiles NRH Tibial Insert is made of polyethylene with a CoCr hinge. The S-ROM Noiles NRH Tibial Insert has two hinge bearings and articulates with an appropriately sized hinged femoral component and tibial component.

TGA Public Summary