FDA Grants DePuy Synthes 510(k) Clearance for VELYS™ Robotic-Assisted System in Partial Knee Replacement

Saturday, June 08, 2024

Johnson & Johnson MedTech has announced that DePuy Synthes, its Orthopaedics Company, has received 510(k) FDA clearance for the VELYS™ Robotic-Assisted Solution for use in Unicompartmental Knee Arthroplasty (UKA).

This approval expands the application of the VELYS platform, previously used in Total Knee Arthroplasty (TKA) across 20 markets and over 55,000 procedures. The platform helps surgeons by preserving soft tissue, predicting joint stability, and restoring knee function.

The new UKA application supports both medial and lateral procedures and allows for precise implant placement without needing a CT scan. It is compatible with the SIGMA™ HP Unicondylar Knee System and the reusable INTUITION™ INSTRUMENTS.

The SIGMA™ HP Implant has shown better 12-year survivorship compared to its class, according to national joint registry data.

“We are focused on continuously enhancing the capabilities and user experience of our VELYS™ Enabling Technology portfolio”.

“This robotic-assisted solution with our proven implant for UKA addresses key needs in the partial knee replacement segment, such as accuracy and simplicity, that other systems do not fully meet.

Data and analytics are central to our platform, offering real-time, actionable insights for surgeons to make patient-specific operative decisions, ultimately aiming to improve outcomes and provide personalized care at scale.”

Unicompartmental knee arthroplasty, or partial knee replacement, offers benefits like bone preservation and shorter recovery times. UKA provides clinical advantages and greater economic efficiency for patients, providers, and payors compared to TKA. However, it is underutilized due to challenges like smaller incisions and limited visibility.

Robotics can help address these challenges in manual partial knee replacements by providing intra-operative insights, ensuring accurate implant alignment and positioning, and achieving more consistent outcomes.

“Partial knee replacement challenges include limited access and visibility, leading to a longer learning curve and outcome variability. Precise alignment and optimal implant placement are crucial for long-term success, and achieving this consistently remains a need in the UKA space,” said Dr. John Redmond, an orthopedic surgeon in Jacksonville, FL.

“The VELYS™ Robotic-Assisted Solution for UKA will facilitate a more personalized procedure with reproducible outcomes. Its planning and balancing tools offer better precision and accuracy. I look forward to its use in UKA procedures, especially in ambulatory surgery centers where its compact size and image-free technology will enhance efficiency.”

Key features of the VELYS™ Robotic-Assisted Solution for UKA include:

  • The PROADJUST™ PLANNING SCREEN for personalized planning, ensuring precise implant placement, alignment, and balance relative to soft tissue.
  • An ACCUBALANCE™ GRAPH for personalized balancing throughout the full range of motion.
  • Compatibility with the SIGMA™ HP Unicondylar Knee System, which has demonstrated improved 12-year survivorship compared to its class.
  • A complete UKA workflow with specific functionality for UKA procedures.

The system will be showcased at the Annual Meeting of the American Association of Hip and Knee Surgeons in November, with details on commercial availability to be announced.


Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital Congress