Search Results

Total hip components are indicated uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

The Synergy HA Coated Porous Femoral Stem is designed uncemented use only and for single use only.

Synergy HA Coated Porous Femoral Stems are manufactured from titanium material (Ti-6A1-4V, ASTM F1472) and are porous coated with bead material manufactured from titanium material (Ti-6AI-4V, ASTM F67, Grade 2, with a mesh size of -- 45/+60. These stems are designed for use with existing Smith & Nephew cobalt chrome or ceramic modular femoral heads with a 12/14 taper.

The provided text is a 510(k) summary for the Synergy HA Coated Porous Femoral Stems, which describes the device, its intended use, and claims substantial equivalence to legally marketed devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, specific study details, or performance metrics.

Specifically, the document states: "Performance characteristics: Data indicate that Synergy HA Coated Porous Femoral Stems are substantially equivalent to identified legally marketed devices." This implies that testing was done to demonstrate substantial equivalence, but the details of that testing, including acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, are not provided within this summary.

Therefore, I cannot populate the table or provide answers to the requested questions based on the given input.

To answer your questions, I would need a different type of document, such as a detailed study report, clinical trial results, or a more comprehensive technical summary that outlines the specific tests performed and their results against predefined criteria.

Ask a specific question about this device