Device Dossier

ic-head CoCrMo taper 12/14 - Metallic femoral head prosthesis

Device Dossier for ic-head CoCrMo taper 12/14 - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Life Healthcare).…

Intended purpose

The ic-heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company and used in hip joint arthroplasty. The ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head. Hip joint arthroplasty is indicated, if - severe joint destruction with significant impairment where other therapeutic measures are not more promising, - severe joint pain due to degenerative or rheumatoid arthritis, joint fractures or bone necrosis, - post-operative conditions after previous surgery with or without the use of implants. Indications for the application of ic - ball heads: - Primary total hip arthroplasty of the hip joint affected by arthrosis, - Revision hip arthroplasty.

Functional description

Constructed from CoCrMo alloy. The ic - ball heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company. The heads are only allowed to articulate with Polyethylen-Inserts or Polyethylene-acetabular cups. The head sizes with the longest neck length provide a collar. The ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head.

TGA Public Summary