(79 days)
The Smith & Nephew PiGalileo System TKR is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.) Examples of some surgical procedures include but are not limited to:
- Total knee replacement supporting bone referencing technique .
- Total knee replacement supporting ligament balancing technique .
- Minimally invasive total knee replacement .
The PiGalileo Navigation System is a software-controlled sterotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.
The PiGalileo TKR V2.1 and PiGalileo TKR CAS V4.0 applications are surgical techniques for computer assisted navigation that leverages PiGalileo Total Knee Replacement (TKR) instruments as well as a number of non-navigated knee instruments for total knee replacement with the intent to optimally position knee prostheses during total joint arthroplasty.
The provided text describes a medical device, PiGalileo TKR V2.1 and TKR CAS V4.0, which is a computer-assisted orthopedic surgery system for total knee replacement. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The text is a 510(k) summary and FDA clearance letter, which mainly focuses on device description, classification, indications for use, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from the given input.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).