Device Dossier
EP-FIT PLUS REXPOL Insert Hooded - Non-constrained polyethylene acetabular liner
Device Dossier for EP-FIT PLUS REXPOL Insert Hooded - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class…
- GMDN category: Non-constrained polyethylene acetabular liner
- Sponsor: Smith & Nephew
Intended purpose
An acetabular component of the EP-FIT PLUS Press-Fit cup system. The EP-FIT PLUS REXPOL Insert Hooded is intended to be used for the following indications: • All forms of arthritis • Progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint • Femoral head necrosis • Fractures in the region of the femoral neck or hip joint • Status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement
Functional description
A sterile non-cemented REXPOL (highly cross-linked polyethylene) acetabular insert having a raised shoulder of 15 degrees intended as luxation protection. The insert should be positioned in the direction in which there is the greatest risk of luxation and the shoulder position of the insert may be adjusted in 30 degree increments. The REXPOL Hooded insert is impacted into the acetabular shell using an inserter/impactor.