(90 days)
The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.
The Interax® Total Knee System consists of a variety of components: Femoral Component, Tibial Baseplate, Tibial Inserts (standard condylar and high conformity condylar, available in two halves), All Polyethylene Patellar Components (resurfacing and inset designs), Femoral Extension Stems, Tibial Extension Stems (cylindrical and cruciform styles), and Tibial Wedges.
The provided text is related to a 510(k) submission for the Interax® Total Knee System, a medical device. This document is a premarket notification for a Class II medical device, indicating that its approval is based on demonstrating substantial equivalence to a predicate device already on the market, rather than new clinical trials demonstrating safety and effectiveness.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way described in the prompt (i.e., with specific performance metrics, sample sizes, expert ground truth, etc.). This type of detailed performance criteria and study results are typically generated for novel devices or those undergoing PMA (Premarket Approval), not for 510(k) submissions that rely on substantial equivalence.
Instead, the document states:
- "Testing was presented in accordance with the FDA Total Knee Guidance Document." This implies that the device met generally accepted testing standards relevant to knee implants (e.g., mechanical, wear, fatigue testing), but the specific acceptance criteria and results are not detailed.
- The FDA's letter confirms substantial equivalence to predicate devices: Duracon® Total Knee System (Howmedica) and Kinemax® Plus Total Knee System (Howmedica).
Therefore, I cannot provide the requested table and detailed study information based on the input text. The prompt's requirements (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance) are not typically found in a 510(k) summary focused on substantial equivalence.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.