Zimmer Biomet gets 510(k) for robotic knee surgery system

Dive Brief:

Zimmer Biomet Friday said FDA gave 510(k) clearance to its Rosa system for robotically-assisted total knee replacement surgeries.
The Rosa Knee platform combines Zimmer’s robotic technology, already on display in products like Rosa Brain for neurosurgical procedures, with its knee implants to help surgeons personalize patient surgeries through the use of computer technology to control surgical instruments, the company said.
The platform can assist with bone resections and help surgeons assess soft tissue to determine implant positioning during the operation.

Dive Insight:

Medtech companies are racing to incorporate robotic platforms into their surgical offerings.

Medtronic announced Monday the first patients had been treated with its Mazor X Stealth Edition robotic system for spine surgery, following the company's $1.7 billion acquisition of Mazor Robotics in 2018. Johnson & Johnson is also readying a challenge to Intuitive Surgical's dominance set for a 2020 market launch.

With the Rosa Knee’s clearance, Zimmer Biomet can now go head to head in robotic knee replacement surgery against longtime orthopaedics rival Stryker, whose Mako platform has given the company significant market share.

Warsaw, Indiana-based Zimmer delved into the robotics space in 2016 with the acquisition of France’s Medtech SA. CEO Bryan Hanson has played his cards close to the vest on the company’s strategy in robot-assisted surgery but did say last year that it is focused on integrating the system in a way that avoids disrupting surgical flow.

Stryker, for its part, has not been shy about touting the benefits of its Mako system in knee replacement surgery. During its third-quarter earnings update in October, the Kalamazoo, Michigan-based company said the robot helped drive sales growth in knee replacements and use of the system in treatment was found to result in less pain, better functional recovery and shorter hospital stays for patients in a study.

In announcing FDA's clearance of the Rosa Knee system, Zimmer said the platform includes 3D preoperative planning tools and real-time intra-operative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion analysis to potentially improve restoration of natural joint movement.