(119 days)
The MAKO Modular Knee Compartmental Implant System is indicated for single or multi-compartmental knee replacement used in conjunction with the MAKO Tactile Guidance System in individuals with osteoarthritis or post traumatic arthritis of the medial tibiofemoral and/or patellofemoral articular surfaces.
The MAKO Modular Knee Compartmental Implant System is for single use only and is intended for implantation with bone cement.
The MMKC is composed of a unicompartmental implant system (MMKC-Uni) and a PF implant system (MMKC-PF). MMKC-Uni and MMKC-PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. MMKC-UNI is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
This document is a 510(k) summary for the MAKO Surgical Corp. Compartmental Knee Implant System (MMKC). It describes the device, its components, materials, sterilization, and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses solely on the regulatory submission and declaration of substantial equivalence to predicate devices, without presenting performance data.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.