Device Dossier

S-ROM Noiles Dome Patella - Polyethylene patella prosthesis

Device Dossier for S-ROM Noiles Dome Patella - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor DePuy Synthes). ARTG…

Intended purpose

The S-ROM Noiles Dome Patella is the petalla component of the S-ROM NOILES Rotating Hinge Knee system which is indicated for use with bone cement in 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 or trauma.

Functional description

The S-ROM Noiles Dome Patella is made from polyethylene and is cemented onto the natural patella. The S-ROM Noiles Dome Patella also contains an x-ray detectable wire of CoCr.

TGA Public Summary