Device Dossier
GLOBAL UNITE Reverse Fracture Epiphyseal Body - Reverse shoulder prosthesis body
Device Dossier for GLOBAL UNITE Reverse Fracture Epiphyseal Body - Reverse shoulder prosthesis body (Reverse shoulder prosthesis body, Class III, sponsor…
- GMDN category: Reverse shoulder prosthesis body
Intended purpose
The GLOBAL UNITE Reverse Fracture Epiphyseal Body is one component of GLOBAL UNITE Platform Shoulder System and is intended for use in total anatomic, hemi, and total reverse arthroplasty shoulder replacement procedures in skeletally mature patients
Functional description
The GLOBAL UNITE Reverse Fracture Epiphyseal Body is manufactured from titanium alloy. The device includes Porocoat along the proximal circumference and is designed to achieve biological fixation to bone without the use of bone cement on the epiphyseal component, however the device is designed to be affixed to bone with or without bone cement. The GLOBAL UNITE Reverse Fracture Epipyseal Body is used in conjunction with the GLOBAL UNITE Shoulder System or the DELTA XTEND Reverse Shoulder System