(38 days)
The Fortitude Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Fortitude, cleared as a cement restrictor via K021719, is currently crafted from titanium alloy (ASTM F136). The purpose of this special 510(k) is to obtain clearance to market a PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026) version of Fortitude. The modification does not change the intended use or the fundamental scientific technology of the device.
As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press fit into small holes in the implant.
Fortitude is a hollow device with texture on two opposing flat sides, and is offered in straight and tapered styles of various sizes. Fortitude is intended for restriction of bone cement in the distal femoral canal (see figure below).
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Instead, the document is a 510(k) summary for a Special 510(k) submission for the Spinal Concepts, Inc. Fortitude™ Cement Restrictor. This submission is for a modification of an already cleared device (K021719) to introduce a new material (PEEK OPTIMA™).
Key points from the document indicating why this information is missing:
- "No mechanical tests were performed to support this application." This explicitly states that performance tests, which would typically establish acceptance criteria and demonstrate performance, were not conducted for this specific 510(k) submission. The clearance relies on substantial equivalence to the predicate device and the new material's general properties and biocompatibility.
- The document primarily focuses on the device description, indications for use, and regulatory correspondence regarding the 510(k) clearance process.
- The FDA letter confirms substantial equivalence based on the provided information and imposes a specific warning about spinal indications, but does not refer to new performance data.
Therefore, I cannot populate the requested table or sections based on the provided text, as the necessary information regarding acceptance criteria and performance studies is not present.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.