(86 days)
RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- Lateral unicondylar
- Patellofemoral
- Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS MCK is for single use only and is intended for implantation with bone cement.
The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
The provided document is a 510(k) summary for the MAKO Surgical Corp. Restoris MultiCompartmental Knee System (Restoris MCK). This document describes the device, its components, materials, and intended use, and states its substantial equivalence to a predicate device.
However, it does not contain any information regarding specific acceptance criteria, performance data, or detailed study methodology (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, or MRMC studies) related to the device's clinical or algorithmic performance.
The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of performance testing against predefined acceptance criteria from a study.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the text provided. The 510(k) summary focuses on the device description and its substantial equivalence to a predicate device, as opposed to a detailed performance study with specific metrics and acceptance criteria.
§ 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.