(90 days)
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.
The Clinical Indication for Use is:
"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."
The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.
Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus.
Materials: Ti-6Al-4V NiTi alloy (locking system)
The provided text describes a 510(k) summary for a "Segmental Defect Replacement System." This document is a premarket notification for a medical device aiming to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the specific information requested regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not present in the provided text.
The document focuses on comparing the proposed device to existing predicate devices based on:
- Intended Use: Reconstruction of the humeral diaphysis with extensive bone lesions due to metastatic disease, myeloma, or lymphoma, placing the humerus at risk for pathologic fracture.
- Design: Modular bistemmed intramedullary rod system with a rigid cam locking mechanism for intraoperative adjustment after cementing components.
- Materials: Ti-6Al-4V, NiTi alloy (locking system).
The document states: "The Segmental Defect Replacement System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices." However, it does not provide details about the specific acceptance criteria for these tests, the performance metrics achieved, or the study design/results for demonstrating this substantial equivalence beyond this general statement.
In summary, the provided content is a regulatory submission for substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria and study results.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.