(16 days)
The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to noninflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee, and revisions of previously failed knee replacements. This device is for use with bone cement
There are two components introduced into the Ascent Knee System which are as follows: the XXL cobalt chrome femoral component and the XXL titanium femoral augments.
Primary Femoral Component
The Ascent primary femoral component is available in either porous or Interlok finishes. The femoral component is composed of cast cobalt chromium (Co-Cr-Mo), conforming to ASTM specification F-75.
Augments
The Ascent Knee System has independent Ti-6A1-4V femoral augments, which are designed to replace damaged or diseased bone. There are two types of augments available, posterior and distal augments. The posterior augments come in 4mm and 8mm thickenesses, while the distal augments are available in 4, 8, and 12mm thicknesses. The posterior and distal augments are available in 6 sizes.
This document is a 510(k) premarket notification for the Ascent Knee System. It is a notification to the FDA that a device is substantially equivalent to a legally marketed predicate device. This type of document does not contain information on acceptance criteria or studies proving performance as it is not a clinical trial or performance study report.
Therefore, I cannot provide the requested information from the provided text. The document's purpose is to establish substantial equivalence for regulatory approval, not to detail device performance studies against acceptance criteria.
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.