Search Results

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• · Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• · Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The modular Signature Ceramic Femoral Head is composed of alumina matrix composite with zirconia reinforcement, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on Signature Orthopaedics' range of femoral heads. The device is compatible for use across any of Signature Orthopaedics' total hip component range, and articulates with UHMWPE acetabular liner.

This document is a 510(k) Premarket Notification for a medical device called the "Signature Ceramic Femoral Head." It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Thus, the questions regarding AI/algorithm performance related to acceptance criteria, ground truth, expert opinions, and training/test sets are not applicable to this type of medical device submission.

This document pertains to a physical orthopedic implant, not a software algorithm or AI-powered diagnostic tool. The "acceptance criteria" discussed in this document refer to the results of non-clinical (mechanical) testing of the physical implant, not the performance metrics of an AI model.

Therefore, I cannot provide the requested information regarding AI device performance metrics, sample sizes for AI test/training sets, or expert involvement in establishing AI ground truth, as this information is not present in the provided text and is not relevant to this type of device submission.

Ask a specific question about this device