Home » Tech » Stryker & Medtronic: New Orthopedic Robots Launch & FDA Clearance

Stryker & Medtronic: New Orthopedic Robots Launch & FDA Clearance

by Lisa Park - Tech Editor

The orthopedic robotics field is seeing increased activity, with two major players, Stryker and Medtronic, recently achieving significant milestones in their respective robotic surgery systems. These developments signal a growing trend toward robotic assistance in orthopedic procedures, promising greater precision and potentially improved patient outcomes.

Stryker launched its Mako Robotic Power System for total knee replacements in February . Unlike fully autonomous surgical robots, the Mako system is designed for surgeons who prefer to retain a degree of manual control. According to Stryker, the system caters to surgeons “interested in robotic technology who still want to use a manual power tool.” This approach suggests a focus on augmenting, rather than replacing, surgical skill. The system is currently in a limited market release, indicating a phased rollout as the company gathers data and refines the technology.

The core of the Mako system lies in its robotic arm, which assists surgeons during the knee replacement procedure. While Stryker hasn’t detailed the specifics of the robotic assistance, such systems typically provide enhanced accuracy in bone preparation, implant placement, and soft tissue balancing. This precision can lead to better implant alignment, reduced pain, and faster recovery times for patients. The limited release will allow Stryker to gather real-world performance data and refine the system before a wider launch.

Medtronic, meanwhile, has received FDA 510(k) clearance for its Stealth AXiS system on . This system represents a more comprehensive integration of technologies, combining surgical planning, real-time navigation, and robotic assistance into a single platform specifically for spine surgery. The Stealth AXiS builds upon Medtronic’s existing Mazor robotic platform, acquired in , and integrates it with the company’s StealthStation navigation technology.

The significance of the Stealth AXiS lies in its holistic approach. Traditionally, surgeons have relied on separate systems for planning, navigation, and robotic execution. The AXiS system aims to streamline this process, offering a more cohesive and efficient workflow. The system’s modular design allows for flexibility in how it’s deployed, accommodating both hospital settings and ambulatory surgery centers. This adaptability is crucial for wider adoption, as not all facilities have the infrastructure to support complex robotic systems.

According to Medtronic, the Stealth AXiS system allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real-time during surgery, without the need for repeated imaging. This is a key advancement, as minimizing radiation exposure for both patients and surgical staff is a constant priority. The system’s AI-powered planning capabilities, integrated through Medtronic’s AiBLE ecosystem, further enhance precision and personalization. AiBLE combines artificial intelligence, data analytics, and services to support surgeons throughout the entire surgical process, from pre-operative planning to post-operative analysis.

The Stealth AXiS is initially cleared for spine surgery, but Medtronic is actively working to expand its capabilities to include cranial and ear, nose, and throat (ENT) procedures, pending additional FDA 510(k) clearance. This expansion would position the system as a versatile robotic platform for a broader range of surgical specialties.

These developments come amidst a growing market for orthopedic robotics. The spinal technologies sector is estimated at $15 billion, and companies are increasingly investing in robotic solutions to gain a competitive edge. Augusta Health in Fisherville, Virginia, recently added Medtronic’s Mazor spine robot in January , demonstrating the growing demand for these technologies. Ortho Rhode Island was the first facility in its state to adopt Stryker’s Mako robot for reverse shoulder replacements earlier in February .

Hoag Orthopedic Institute in Irvine, California, reached a milestone of 1,500 robot-assisted surgeries in 2025, with robot case volume increasing by 159% over the previous year. This demonstrates a clear trend toward increased utilization of robotic surgery in orthopedic practices. However, the cost of these systems remains a significant barrier to entry for many hospitals and surgery centers.

While the long-term impact of these technologies remains to be seen, the recent advancements from Stryker and Medtronic suggest that robotic assistance is poised to become an increasingly integral part of orthopedic surgery. The focus on both augmenting surgical skill (Stryker’s Mako) and providing a fully integrated platform (Medtronic’s Stealth AXiS) indicates a diverse approach to innovation in this rapidly evolving field.

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