Four robotic systems account for most robotic-assisted knee replacements in the US. Each is made by a major implant company, and each works only with that company’s own knee implants. So the robot your surgeon uses usually goes hand in hand with the implant they prefer.
In every case the surgeon still does the operation. The robot helps plan the bone cuts and keeps them on target. For how robotic surgery works in general, and what the research shows, see Robotics and alignment.
Systems are listed in the order they first reached the US market for knee surgery. This is not a ranking. Descriptions of features come from each company and from industry press, and are labeled that way.
How long each system has been around
Key US milestones, 2004 to 2026
Scroll sideways to see the full timeline.
Dates from company announcements, FDA records and industry press listed under Sources. Clearance means FDA 510(k) clearance in the US.
Years on the US market for knees
Scroll sideways to see the full table.
System
First US knee use
Total knee cleared
Years of total knee use (2026)
Mako (Stryker)
2006 (partial knee)
2015
11
CORI / NAVIO (Smith+Nephew)
2012 (NAVIO partial knee)
2017 (NAVIO); CORI 2020
9 (NAVIO) / 6 (CORI)
ROSA (Zimmer Biomet)
2019 (total knee)
2019
7
VELYS (DePuy Synthes)
2021 (total knee)
2021
5
The four systems
Mako
Stryker
The longest history of the four in knee surgery, with partial knee cases since 2006.
What the maker says it offers
Builds a 3D plan for each patient from a CT scan taken before surgery.5,6
A robotic arm holds the saw and keeps each cut inside the planned boundaries, while the surgeon guides it.6
Used for total knee, partial knee and hip replacement, with Stryker’s own implants, such as the Triathlon knee.3,4
Keep in mind: Needs a CT scan before surgery, which means an extra imaging appointment and some radiation exposure.
Timeline
2005MAKO Surgical, founded in 2004, gets FDA clearance for its first robotic guidance system.1
2025ROSA Knee with OptimiZe cleared, with automated alignment planning; US rollout planned for early 2026.15,16
VELYS
DePuy Synthes (Johnson & Johnson MedTech)
Used for total knees since 2021.
What the maker says it offers
Mounts directly on the side rail of the operating table, giving it a small footprint.18,22
No CT, MRI or X-ray needed before surgery. The knee is mapped during the operation.18,22
Shows predicted gap balance before bone cuts are made. Used with DePuy Synthes’ ATTUNE knee, and the SIGMA HP partial knee.18,19
Keep in mind: Works with DePuy Synthes implants. It is the newest of the four, so it has the shortest track record.
Timeline
2018Johnson & Johnson acquires Orthotaxy, the developer behind VELYS.17
2021FDA clears the VELYS Robotic-Assisted Solution for total knee replacement (January 14).18
2024VELYS cleared for partial knee replacement (June).19
What the evidence shows
The features above describe what each system is designed to do. Whether they make patients feel better is a separate question.
In the RACER-Knee trial, published in 2026, 339 patients were randomly assigned to Mako or to conventional surgery. The robot placed implants more precisely, but patients reported no meaningful difference in how their knee felt at one year.20
A 2026 review of randomized trials found no difference in pain, function or satisfaction between robotic and conventional knee replacement, with longer operating times for robotic cases.21
Head-to-head trials comparing these four systems with each other are rare, so there is no good evidence that one system leads to better results than another.
Your surgeon’s experience with whichever system they use, and with knee replacement overall, is likely to matter more than the brand of robot. More on this in The future of knee replacement technology.
Questions to ask about robotic surgery
Which robotic system do you use, and how many robotic knee replacements have you done with it?
Will I need a CT scan or special X-rays before surgery?
Does using the robot change which implant I get?
Does it change the cost to me, the length of surgery or my recovery plan?
What would you do differently if we didn’t use the robot?
MAKO comes out with RIO system, Restoris implants. Medical Device Daily / BioWorld. 2009. bioworld.com
MAKO Surgical Corp. Receives FDA clearance to market Version 2.0 Tactile Guidance System (RIO). Press release. December 2, 2008. biospace.com
Stryker gets FDA nod to use Mako robot for total knee reconstruction. Fierce Biotech. August 2015. fiercebiotech.com
Stryker launches Mako total knee application. ORTHOWORLD. 2017. orthoworld.com
Stryker showcases next generation of Mako SmartRobotics at AAOS 2025 Annual Meeting. Press release. March 11, 2025. stryker.com
Surgical robots: why Stryker’s Mako is driving knee replacement growth. The Robot Report. 2019. therobotreport.com
U.S. robot surgery market gets a new player with FDA nod for Blue Belt Technologies. MassDevice. December 11, 2012. massdevice.com
FDA 510(k) clearances for Blue Belt Technologies, including Real Intelligence CORI (K193120, February 14, 2020). 510kdatabase.net
Smith+Nephew launches Real Intelligence and CORI Surgical System. Press release. July 14, 2020. smith-nephew.com
Smith+Nephew expands reach of its CORI handheld robotic system. MassDevice. November 24, 2021. massdevice.com
Smith+Nephew Third Quarter 2026 Trading Update. November 4, 2026. investegate.co.uk
FDA clears Zimmer Biomet’s ROSA Knee. Ryan Orthopaedics (OTW). January 2019. ryortho.com
Zimmer Biomet receives FDA clearance for ROSA Knee System for robotically-assisted surgeries. Press release via DotMed. January 2019. dotmed.com
Zimmer Biomet receives FDA clearance for ROSA Partial Knee System. Press release. April 20, 2021. investor.zimmerbiomet.com
Zimmer Biomet receives U.S. FDA clearance for enhanced version of ROSA Knee robotic technology (ROSA Knee with OptimiZe). Press release. November 14, 2025. investor.zimmerbiomet.com
FDA clears Zimmer Biomet’s updated knee robotic technology. Medical Design & Development. November 2025. medicaldesigndevelopment.com
J&J wins clearance for VELYS Robotic-Assisted Solution. MD+DI. January 22, 2021. mddionline.com
DePuy receives clearance for ortho robotic system (VELYS, cleared January 14, 2021). Ryan Orthopaedics (OTW). January 2021. ryortho.com
DePuy Synthes Velys earns FDA nod for partial knee replacements. Becker’s Spine Review. June 2024. beckersspine.com
Parsons H, Metcalfe A, Griffin J, et al. Robotic-arm-assisted versus conventional total knee replacement (RACER-Knee): a randomised controlled trial. Lancet. 2026. doi:10.1016/S0140-6736(26)00986-4
Abdelaziz O, et al. Comparative pain relief and functional outcomes following robotic-assisted versus conventional total knee arthroplasty: a GRADE-assessed meta-analysis with meta-regression of randomized controlled trials. J Robot Surg. 2026;20(1). doi:10.1007/s11701-026-03934-0
DePuy Synthes earns FDA clearance for knee-replacement robotic-assistance platform. FDAnews. January 22, 2021. fdanews.com