Device Information

The ExactechGPS System assists surgeons during arthroplasty by providing real-time anatomical data. This image-guided system computes and displays critical information, such as distances and angles for prosthetic placements. It integrates trackers that communicate with a hardware station, providing live feedback to the surgeon during surgery.

Indications

The ExactechGPS System is intended to assist surgeons during stereotaxic surgery. It helps locate anatomical structures and align prostheses. The TKA Pro software is specifically for Total Knee Arthroplasty.

Intended Use

The ExactechGPS System is designed for professional use during orthopedic surgeries, such as Total Knee Arthroplasty. Only qualified healthcare professionals should use this device to align and place prostheses in surgical settings.

Availability

It is available for use by professionals by prescription only.

Study Results

• Nonclinical and Safety Testing: The ExactechGPS System underwent general function tests, electrical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), photobiological safety analysis (EN 62471), and sterilization validation (ISO 11135-1:2014). All tests showed compliance with relevant standards.

Regulatory Information

• Regulation Number: 21 CFR 882.4560
• Regulatory Class: Class II
• Product Code: OLO
• 510(k) Number: K233299
• This system must comply with FDA regulations on quality systems, nonconforming product handling, and corrective and preventive actions (21 CFR 820). Additionally, it meets sterilization standards and electrical safety regulations.

Manufacturer Information

• Name: Blue Ortho
• Address: 22 Chemin du Vieux Chêne, 38240 Meylan, France
• Contact Person: Matthieu Coic
• Contact Details: Phone: +33 (0)4 58 00 35 25, Email: matthieu.coic@blue-ortho.com

Predicate Device Information

• Predicate Device Name: ExactechGPS System (K213877)
• The current device features minor updates, such as a new optical localizer and an integrated wireless tablet. These updates avoid obsolescence without changing the device’s core functionality.

Implications

The ExactechGPS System enhances precision in orthopedic surgeries, particularly knee replacements. The system’s updates improve its ease of use, but its overall impact on surgery remains consistent with its predecessor.

References

1. ExactechGPS System. 510k Number K233299. Blue Ortho: FDA summary link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233299
2. Blue Ortho manufacturer website: https://blue-ortho.exac.com/