Buying guide
Stryker Mako SmartRobotics
By Stryker · surgical
- Price
- $1,000,000-$1,500,000· actual sale price
- Availability
- Internal use only (not for retail).
- Maturity
- commercial
- Real-world use
- Yes, 7 verified deployments
Stryker's Mako (Mako SmartRobotics) is a surgeon-guided robotic arm for orthopedic joint replacement and the large-footprint, CT-based, multi-procedure archetype of DEPLOY's orthopedic surgical sub-cohort. It pairs CT-based 3D pre-operative planning with intra-operative haptic boundary control (AccuStop physically constrains the saw or burr to the planned resection zone) and real-time optical bone tracking. Critically, it is AI-augmented but surgeon-controlled, not autonomous: the surgeon holds and guides the arm and makes every cut; the robot does not move or cut on its own, the same assistive class as Intuitive's da Vinci. Cleared procedures span partial and total knee (total knee August 2015), cementless total knee, total hip and a hip-revision feature, Mako Spine (510(k) K241517, May 2024, pedicle-screw placement) and Mako Shoulder 1.0 (510(k) K242373, November 2024, reverse shoulder arthroplasty). Sold in 45-plus countries by Stryker (NYSE: SYK). Cap-flag: Stryker frames itself in SEC filings as one of four leading global competitors, not a specific market-share percentage; aggregator share figures are not verified. As enterprise B2B surgical equipment, there is no consumer price.
Readiness
Stryker Mako SmartRobotics is internal use only (not for retail) at $1,000,000-$1,500,000 (actual sale price), the 1 capability claim on file is all teleoperated-assisted with verified, 7 verified deployments are on file, and 9 incidents are on record.
- Availability
- internal-only
Internal use only (not for retail).
- Price honesty
- actual-sale-price
One price on file: $1,000,000-$1,500,000 (actual sale price).
- Capability honesty
- teleoperated-assisted
1 reviewed claim: teleoperated-assisted, verified.
- Real-world use
- commercial
Maturity: commercial. 7 verified deployments in the registry.
- Safety record
- incidents-on-file
9 incidents on record across 7 verified deployments.
What it claims to do
- Assists surgeryteleoperated-assisted· verifiedevidence ↗
Price
- $1,000,000-$1,500,000actual sale price · Stryker Mako SmartRobotics system — capital equipment unit price approximately $1M–$1.5M per installation, documented in hospital procurement analyses, health technology assessment reports, and Stryker SEC 10-K filings (CIK 310764). Mako system includes the robotic arm, haptic guidance software, implant planning suite, and initial training; ongoing per-procedure implant costs are separate. Stryker reports Mako-assisted procedures as a segment driver in investor presentations. ↗ · as of 2023-01-01
Real-world use
- Ireland operated by Stryker2025-01-01
- Global operated by Stryker2024-06-01
- United Kingdom operated by Stryker2017-01-01
- Japan (JGSDF Trials) operated by Stryker2017-01-01
- Germany operated by Stryker2017-01-01
- Australia operated by Stryker2015-01-01
- United States operated by Stryker2006-01-01
Safety record
- Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)2025-04-01
- Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)2024-08-15
- Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts2024-08-07
- Stryker Mako Total Knee software correction over 'error #3' codes when switching applications2024-05-28
- Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking2023-03-10
- Stryker Mako bone-registration accuracy recall (Class II, 2022)2022-07-01
- Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)2020-11-11
- Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts2020-10-23
- Stryker recalls Mako RIO over loss of system power mid-procedure2017-06-07
Privacy
No privacy practices disclosed or on file for Stryker Mako SmartRobotics.
Specs
No specs on file.
What's under the hood
No brain on file for Stryker Mako SmartRobotics.
Frequently asked questions
Is the Stryker Mako SmartRobotics actually available for purchase?
What does the Stryker Mako SmartRobotics cost?
Does the Stryker Mako SmartRobotics really assists surgery?
Where is the Stryker Mako SmartRobotics being used?
Is the Stryker Mako SmartRobotics safe?
How does the Stryker Mako SmartRobotics handle privacy?
Who makes the Stryker Mako SmartRobotics?
Video
Stryker's milestone film marking the 1,000th global installation of its Mako system (a brand video, not a procedure demonstration). Mako is a surgeon-controlled robotic arm with AccuStop haptic boundaries: the surgeon guides the arm and the boundary constrains it; it does not cut autonomously.
Manufacturer
Stryker (registry record: /companies/stryker)
Compare side by side
- Stryker Mako SmartRobotics vs Hugo RASby Medtronic · surgical
Sources
- Stryker · https://www.stryker.com/
- Stryker to acquire MAKO Surgical for $1.65B ($30/share; announced Sep 25 2013, closed Dec 17 2013) · https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx
- Stryker Form 10-K FY2024: >1M robotic Mako Total Knees + 1.5M total Mako procedures, 45+ countries; 'one of four leading global competitors' · https://www.sec.gov/Archives/edgar/data/0000310764/000031076426000010/syk-20251231.htm
- Stryker receives FDA clearance for Mako Total Knee application (Aug 6 2015) · https://investors.stryker.com/press-releases/news-details/2015/Stryker-Receives-FDA-Clearance-For-Mako-Total-Knee-Application/default.aspx
- Mako SmartRobotics -- Stryker product page; robotic-arm system for total hip, total knee, and partial knee replacement; pre-operative 3D plan plus intraoperative haptic boundary limits autonomous cutting path within surgeon-defined zone · https://www.stryker.com/us/en/joint-replacement/systems/mako_robotic-arm-assisted-surgery.html
- Stryker Mako investor materials; Mako installed in >1,000 hospitals globally; cumulative procedures surpassed 500,000 as of 2022 · https://www.stryker.com/content/dam/stryker/joint-replacement/documents/mako-total-hip-datasheet.pdf
- Mako robotic shoulder replacement makes European debut · https://healthcare-in-europe.com/en/news/europe-debut-mako-robotic-shoulder-replacement.html
- First European case completed with Stryker Mako Shoulder in Ireland · https://www.massdevice.com/first-european-case-stryker-mako-shoulder/
- Mako robotic-arm assisted surgery UK · https://www.stryker.com/gb/en/healthcare-professionals/products/orthopaedics/robotic-arm-assisted-surgery.html
- NHS expands robotic surgery with Stryker Mako · https://www.bbc.com/news/health-68765432
- Stryker reaches 2 million Mako cases · https://www.beckersspine.com/robotics/stryker-reaches-2-million-mako-cases/
- Stryker launches expensive Mako robot for knee replacement · https://medcitynews.com/2017/03/stryker-launches-expensive-mako-robot-knee-replacement-cost-conscious-era/
- Orthopedic Devices in 2026: Stryker Has 3000 MAKO Systems Installed · https://constancyresearchers.com/orthopedic-devices-in-2026-stryker-has-3000-mako-systems-installed-over-50-of-global-knee-procedures-are-now-robot-assisted-and-the-ambulatory-surgery-centre-is-the-markets-new-battlefiel/
- St John of God Subiaco Hospital first in Australia to install cutting-edge orthopaedic surgery robot · https://www.sjog.org.au/our-locations/st-john-of-god-subiaco-hospital/news/news/2025/08/04/01/33/st-john-of-god-subiaco-hospital-first-in-australia-to-install-cutting-edge-orthopaedic-surgery-robot
- Ramsay Health Care makes landmark Australian investment in robotic surgical technology · https://www.ramsaynews.com.au/General-News/Ramsay-Health-Care-makes-landmark-Australian-investment-in-robotic-surgical-technology
- Stryker reaches robotic surgery milestone · https://www.stryker.com/us/en/about/stryker-news/2024-robotic-assisted-surgery-milestone.html
- Stryker Mako reaches 1,000 installation milestone · https://www.massdevice.com/stryker-mako-smart-robotics-1000-installations/
- Stryker high-growth offense 2025 · https://www.orthoworld.com/strykers-high-growth-offense-surges-to-end-2025/
Recent coverage
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Keep reading
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Canonical: https://deploy.report/models/mako-smartrobotics