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…
- GMDN category: Polyethylene patella prosthesis
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.