Hipgraphics System One W/Orthotool

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K894402 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• What types of orthopedic procedures is the Hipgraphics System One with Orthotool primarily designed to assist with during surgery?

  The Hipgraphics System One with Orthotool is specifically designed to assist in precise surgical planning and intraoperative guidance for orthopedic procedures. Its integration of radiographic imaging and orthopedic alignment tools makes it particularly useful for procedures requiring accurate bone alignment, such as joint replacements (e.g., hip or knee arthroplasty) or fracture repairs. The system helps surgeons visualize and confirm alignment in real-time using X-ray imaging.

• Is the Hipgraphics System One with Orthotool intended for single-use or reusable applications in a clinical setting?

  The device is supplied as a reusable medical system, meaning it is intended for repeated use within a radiology department after proper cleaning, maintenance, and sterilization procedures. This design allows hospitals and clinics to maintain the system for ongoing orthopedic surgical support without frequent replacements.

• How is the Hipgraphics System One with Orthotool regulated by the FDA, and what does that mean for its use in hospitals?

  The Hipgraphics System One with Orthotool received FDA clearance through a 510(k) submission (K-number K894402) under the product code LLZ, classified as a Class II device. This means it has been determined to be substantially equivalent to a legally marketed device already on the market. Hospitals can legally use it for its intended radiologic and orthopedic alignment purposes, as it meets FDA requirements for safety and effectiveness in these applications.

• What role did the Radiology (RA) Advisory Committee play in the approval process for this device?

  The Radiology (RA) Advisory Committee provided input during the review process for the Hipgraphics System One with Orthotool. Their advisory role helps the FDA assess whether the device meets the necessary standards for radiographic imaging systems used in orthopedic procedures. While their recommendations are advisory—not binding—they contribute to ensuring the device’s safety, performance, and suitability for its intended clinical applications.

• Are there any specific storage requirements or considerations for maintaining the Hipgraphics System One with Orthotool between uses?

  Since the device is reusable, it must be stored in a clean, dry environment protected from dust, moisture, and physical damage between uses. The manufacturer’s instructions (not provided in the data) likely outline specific cleaning, disinfection, and maintenance protocols to ensure proper functionality and longevity. Proper storage is critical to prevent contamination and mechanical wear, especially for a system used in sterile surgical environments.