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 patella component of the S-ROM NOILES Rotating Knee Hinge System is intended to provide a functional articulating knee joint in skeletally mature patients with a severely painful knee and impaired knee function and/or after a failed previous implant.

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