Howmedica Osteonics Restoration Anatomic Acetabular Component System - HSA Registration DE0508357
Access comprehensive regulatory information for Howmedica Osteonics Restoration Anatomic Acetabular Component System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508357 and owned by Howmedica Osteonics Corp.. The device was registered on August 03, 2023.
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The Restoration Anatomic Acetabular Component System is intended for cementless fixation within the prepared acetabulum. The indications include: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. When used with MDM Liners - 1. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 2. Dislocation risks. The Restoration Anatomic Acetabular Shell is indicated for cementless use only.