Dive Brief:
- Stryker has started a limited market release of its Mako RPS handheld robotic system for total knee procedures, the company said Monday.
- Mako RPS, short for robotic power system, is aimed at surgeons who are interested in robotic technology but want the familiarity of a manual power tool, the company said.
- CEO Kevin Lobo recently told investors Mako RPS could be attractive to surgeons at ambulatory surgical centers and to other physicians who want a simpler alternative to Stryker’s robots.
Dive Insight:
Stryker has installed more than 3,000 Mako robots globally, according to BTIG analyst Ryan Zimmerman. Surgeons use the orthopedic robot in more than two-thirds of Stryker’s U.S. knee procedures and one-third of U.S. hip procedures. However, the company has identified barriers to adoption by some surgeons — issues Mako RPS is intended to address.
“Mako requires a lot of change for the surgeon as well as for the staff,” Lobo said on an earnings call last month. “If you think about this handheld, it really is very simple, very easy to use [and] doesn't require the surgeon to go through that type of transition.”
A Stryker spokesperson said in an emailed statement that Mako RPS for total knee has received 510(k) clearance. The Food and Drug Administration granted Stryker 510(k) clearance for an RPS console, saw, software and other devices in August 2025.
Lobo said the system uses intellectual property from Mako to provide haptic boundaries. Stryker is using the Mako sales force to promote a device that Lobo sees as a bridge between the company’s robotic and manual products. The Stryker CEO predicted Mako RPS will be “an extra accelerator” for Stryker’s knee business.
Mako RPS is only cleared for use in total knee arthroplasty procedures. Surgeons who want to perform multiple types of orthopedic procedures, such as total hip and partial knee replacements, will still need to consider alternatives such as the full Mako robot.
Stryker, which started the first Mako RPS cases in January, disclosed the limited market release as part of its presence at the American Academy of Orthopaedic Surgeons 2026 annual meeting. Lobo said last month that Mako RPS will be on display at the event, which will serve as the “coming out party” for the device.