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The Excia Hip System is intended to replace a hip joint.

The device is intended for:

• Patients suffering from severe hip and disability due to rheumatoid arthritis, osteoarthritis, . traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . epiphysis
• Patients suffering from disability due previous fusion .
• Patients with acute femoral neck fractures .

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without µ CaP®.

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out µ-CaP®. This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore with or without µ-CaP® as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and are available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo and ceramic head can be used with the cemented femoral component. The CoCrMo head can also be used with the Cementless femoral stem.

The provided text describes a 510(k) premarket notification for the Excia Total Hip System with $\mu$-CaP®, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results to prove device performance against specific acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria, a specific study proving the device meets those criteria, or the details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Instead, the document states:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."
• It lists several other guidance documents for specific aspects of orthopedic implant testing (e.g., modified metallic surfaces, plasma-sprayed coatings, modular implant components, femoral stem prostheses, calcium phosphate coating).
• The primary method of demonstrating approval is through Substantial Equivalence to legally marketed predicate devices (Excia Total Hip System (K042344), BiContact Hip System with $\mu$-CaP (K043079), and Trident Acetabular Shells: PS-HA (K001448)).

In the context of a 510(k) submission, "performance data" refers to non-clinical bench testing and adherence to relevant guidance documents to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not typically involve the kind of detailed clinical study data with acceptance criteria and reader studies that would be common for AI/software-as-a-medical-device (SaMD) devices.

Therefore, I cannot populate the table or answer the specific questions as the necessary information is not present in the provided text.

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