Device Dossier
RESTORIS MCK Patella Component - Polyethylene patella prosthesis
Device Dossier for RESTORIS MCK Patella Component - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Polyethylene patella prosthesis
- Sponsor: Stryker
Intended purpose
A patella implant used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. Or for single or multi-compartmental knee replacement when used in conjunction with RIO - the Mako Robotic Arm Interactic Orthopaedic System.
Functional description
A sterile implantable patella component of the RESTORIS® MCK (MultiCompartmental Knee) made of polyethylene (UHMWPE), designed to articulate with an artificial Patellofemoral component. For cemented use only.