Johnson & Johnson Enters Spine Robotics with First Active Spine Robot VELYS SPINE Receiving FDA 510(k) Clearance

On August 2, DePuy Synthes, a subsidiary of Johnson & Johnson, announced the development in collaboration with eCential Robotics ofVELYS SPINE Active Robotic Assistance System, has obtained FDA 510(k) clearance.

VELYS SPINE is mainly used for planning and measuring spinal fusion surgeries of the cervical, thoracolumbar, and sacroiliac spine.This device includes a dual system, which not only has independent navigation capabilities but also the functionality of an active robotic platform, allowing doctors to operate with flexibility.Doctors can also customize surgical guidance according to their own preferences, achieving personalized medical coaching.

DePuy Synthes, a subsidiary of Johnson & Johnson focused on the orthopedics sector, offers a comprehensive range of products in the orthopedic and neurology fields. The company was once ranked as one of the top three global orthopedic device companies and continues to maintain a leadership position in the orthopedics industry.

It is worth noting that,DePuy Synthes has the advanced digital surgery platform VELYS system.The system can assist doctors in planning and guide surgeries, improving the decision-making, precision, and consistency of operations. In June 2024, the FDA approved the system for unicompartmental knee replacement surgery, and it has successfully performed over 100 surgeries worldwide. Recently, the system also received usage authorization in Australia, New Zealand, and Israel.

Spinal fusion is a surgical procedure that connects two or more bones in any part of the spine, primarily used to treat conditions such as spinal stenosis, lumbar disc herniation, and spondylolisthesis. Depending on the bones being connected, spinal fusion can be divided intoPosterior Lumbar Interbody Fusion, Posterolateral Lumbar Fusion, and Anterior Lumbar Interbody Fusion。

Posterior Lumbar Interbody Fusion (PLIF) and Posterolateral Lumbar Fusion are both procedures that stabilize the vertebrae from the back. In Posterior Lumbar Interbody Fusion, an implant is inserted between the vertebral bodies before stabilization. Posterolateral Lumbar Fusion directly stabilizes the vertebrae. Anterior Lumbar Interbody Fusion (ALIF) primarily addresses fractures of the lumbar vertebrae, requiring access from the side of the abdomen to remove the intervertebral discs and remnants of the fractured vertebrae, which are then replaced with autograft or artificial bone, followed by fixation of the vertebrae using stabilizing instruments.

Regardless of the surgical approach, the difficulty is higher than that of general orthopedic surgeries. First, important nerves such as the spinal cord and nerve roots are located near the spine, and the vascular structure is complex. Damage to these structures during surgery may lead to severe consequences such as paralysis or loss of sensation in patients. Second, procedures like laminectomy and interbody fusion require high precision. Careless operation may result in disease recurrence or restrict normal movement of the patient.

To ensure the accuracy of spinal fusion surgery, many teams are attempting to upgrade the procedure by utilizing instruments such as endoscopes.

In 2012, the Osman team initiatedLumbar Interbody Fusion Assisted by Spinal EndoscopyThe pioneering technique not only reduces surgical trauma and lowers the incidence of complications but also facilitates postoperative recovery for patients.

Later, many teams improved this surgical technique. For instance, in 2022, Yang Yang's team from the Department of Spine Surgery at the Third Affiliated Hospital of Sun Yat-sen University published a clinical study titled "Real-time 3D CT Navigation-guided Endoscopic Lumbar Interbody Fusion" in the Chinese Journal of Reparative and Reconstructive Surgery. The team enhanced the endoscopic lumbar fusion technique by adding...3D CT Navigation GuidanceReal-time 3D CT navigation technology provides clear anatomical images, improves surgical accuracy, and has been evaluated based on postoperative patient recovery and recurrence rates, showing an excellent surgical success rate of 96.3%.

In addition, there are also teams attempting to introduce VR technology into spinal fusion surgery. In 2024, eXeX collaborated with Dr. Robert Masson.Introducing Apple Vision Pro into Spinal Reconstruction Surgery, which provides medical staff with the ability to access surgical settings and procedural guidelines through holographic and non-contact methods, has been proven to significantly improve the efficiency of surgical delivery and indirectly enhance patient outcomes. Currently, the team is also attempting to introduce Apple Vision Pro into reverse total shoulder arthroplasty.

Like many surgical procedures, surgical robots are also one of the important development directions in the field of spinal surgery instruments. Since 2004, after the first spinal robot, SpineAssist, developed by Mazor Robotics, was approved, this field has been growing steadily.

Medtronic, Stryker, Zimmer BiometGiant surgical robot companies still dominate this niche track. Currently, domestic companies are relatively concentrated and have formed three distinct competitive tiers. The domestic companies in the first tier include:TINAVI Medical, Xinjun Special, Boshikang, etc.

In 2016, developed by TianzhihangChina's First Spinal Surgery Robot "Tianji Orthopedic Surgery Robot"Approved for marketing. This surgical robot assists in the positioning of surgical instruments or implants during surgery with the help of robotic arms, while being compatible with both 2D and 3D modes. It can accurately move to the planned position and, with the assistance of an orthopedic guide, provide doctors with a precise and stable path for needle insertion.

As of 2021, the "Tianji Orthopedic Surgery Robot" had completed over 20,000 surgeries. The extensive clinical experience provided an opportunity for technological innovation, and in 2020, Tinavi Medical Technologies launched"Tianji 2.0"Compared with the initial version, "2.0" has made significant improvements in intelligence, operational convenience, and user-friendliness. In December 2021, this device received the CSA certification from the Canadian Standards Association.TINAVI Medical Technologies has become the first surgical robot company in China to obtain this certification.

Xin Junte's advantage lies in the navigation system. In 2021, the ORTHBOT surgical robot developed by Xin Junte was officially approved, becomingChina's First Fully Intelligent Orthopedic Surgical Robot with "Navigation + Surgical Operation". This robot includes independently developed modules such as preoperative planning, surgical navigation, and active screw placement. Among these, the surgical navigation technology has broken through long-standing technical barriers held by foreign countries, ending the history of China relying on imported equipment as the foundational navigation system.

Boshicomed places more emphasis on precision, with its core product being the integrated optical-magnetic surgical navigation system. This system utilizesIntraoperative X-ray Images and Preoperative CT, MRI ImagesPerform fusion to achieve tracking of three-dimensional dynamic real-time images, with surgical precision reaching 0.1mm.

Bosicon has also applied this technology to spinal surgery. The optical-magnetic integrated spinal surgical navigation system has achieved the organic integration of optical and electromagnetic tracking technologies for the first time, breaking through the technical barriers of single-source navigation signals. It addresses key technical issues such as the fusion, calibration, simultaneous display on the same device, and free switching of multi-target positioning information sources, achieving sub-millimeter surgical precision and enabling visualized accurate positioning throughout the entire surgical process. Currently, this equipment has been successfully applied in multiple hospitals, including Tangdu Hospital affiliated with the Air Force Medical University and the First Affiliated Hospital of Chongqing Medical University.