# Stryker Mako SmartRobotics

Manufacturer: [Stryker](/companies/stryker)  
Category: surgical

## Summary

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.

## Top line

> 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.

## Readiness

- **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 surgery**: teleoperated-assisted, verified _(evidence: [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))_

## Price

- $1,000,000-$1,500,000, _actual-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.](https://www.stryker.com/us/en/joint-replacement/systems/mako_robotic-arm-assisted-surgery.html)) _as of 2023-01-01_

## Real-world use

- [Ireland](/deployments/stryker-mako-ireland) operated by [Stryker](/companies/stryker), first seen 2025-01-01
- [Global](/deployments/mako-global-deployments) operated by [Stryker](/companies/stryker), first seen 2024-06-01
- [United Kingdom](/deployments/stryker-mako-europe) operated by [Stryker](/companies/stryker), first seen 2017-01-01
- [Japan (JGSDF Trials)](/deployments/stryker-mako-japan) operated by [Stryker](/companies/stryker), first seen 2017-01-01
- [Germany](/deployments/stryker-mako-germany) operated by [Stryker](/companies/stryker), first seen 2017-01-01
- [Australia](/deployments/stryker-mako-australia) operated by [Stryker](/companies/stryker), first seen 2015-01-01
- [United States](/deployments/stryker-mako-us-cumulative) operated by [Stryker](/companies/stryker), first seen 2006-01-01

## Safety record

- [Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)](/incidents/stryker-mako-reamer-missing-screw-maude-2025), 2025-04-01
- [Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)](/incidents/stryker-mako-acetabular-inserter-missing-screw-maude-2024), 2024-08-15
- [Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts](/incidents/stryker-mako-mics-handpiece-characterization-recall-2025), 2024-08-07
- [Stryker Mako Total Knee software correction over 'error #3' codes when switching applications](/incidents/stryker-mako-software-error-recall-2024), 2024-05-28
- [Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking](/incidents/stryker-mako-restoris-mck-baseplate-mislabel-recall-2023), 2023-03-10
- [Stryker Mako bone-registration accuracy recall (Class II, 2022)](/incidents/stryker-mako-bone-registration-recall-2022), 2022-07-01
- [Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)](/incidents/stryker-mako-navigation-revision-overresection-maude-2020), 2020-11-11
- [Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts](/incidents/stryker-mako-mics-handpiece-checkpoint-verification-recall-2020), 2020-10-23
- [Stryker recalls Mako RIO over loss of system power mid-procedure](/incidents/stryker-mako-rio-loss-of-power-recall-2017), 2017-06-07

## 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?

Not available to consumers. In internal use by Stryker.

_Source: [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)._

### What does the Stryker Mako SmartRobotics cost?

Stryker Mako SmartRobotics costs $1,000,000-$1,500,000 one-time (actual sale price).

_Source: [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.](https://www.stryker.com/us/en/joint-replacement/systems/mako_robotic-arm-assisted-surgery.html)._

### Does the Stryker Mako SmartRobotics really assists surgery?

Verified at teleoperator-assisted autonomy; not fully autonomous.

_Sources: [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)._

### Where is the Stryker Mako SmartRobotics being used?

Stryker Mako SmartRobotics is in use at: Ireland operated by Stryker (2025-01-01), Global operated by Stryker (2024-06-01), United Kingdom operated by Stryker (2017-01-01), Japan (JGSDF Trials) operated by Stryker (2017-01-01), and Germany operated by Stryker (2017-01-01), plus 2 more.

_Source: [Mako robotic shoulder replacement makes European debut](https://healthcare-in-europe.com/en/news/europe-debut-mako-robotic-shoulder-replacement.html)._

### Is the Stryker Mako SmartRobotics safe?

Incidents on record: 9 (2 malfunction, 6 recall, 1 injury). See Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE).

_Source: [Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)](/incidents/stryker-mako-reamer-missing-screw-maude-2025)._

### How does the Stryker Mako SmartRobotics handle privacy?

No privacy practices disclosed or on file for Stryker Mako SmartRobotics.

### Who makes the Stryker Mako SmartRobotics?

Stryker Mako SmartRobotics is made by Stryker, based in Kalamazoo, MI, USA.

_Source: [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)._

## Manufacturer

- [Stryker (https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx)](https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx)

## Compared to

- [Hugo RAS](/consumer/models/medtronic-hugo)

## Sources

1. [Stryker](https://www.stryker.com/)
2. [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)
3. [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)
4. [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)
5. [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) · 2023-01-01
6. [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) · 2022-01-01
7. [Mako robotic shoulder replacement makes European debut](https://healthcare-in-europe.com/en/news/europe-debut-mako-robotic-shoulder-replacement.html)
8. [First European case completed with Stryker Mako Shoulder in Ireland](https://www.massdevice.com/first-european-case-stryker-mako-shoulder/)
9. [Mako robotic-arm assisted surgery UK](https://www.stryker.com/gb/en/healthcare-professionals/products/orthopaedics/robotic-arm-assisted-surgery.html)
10. [NHS expands robotic surgery with Stryker Mako](https://www.bbc.com/news/health-68765432)
11. [Stryker reaches 2 million Mako cases](https://www.beckersspine.com/robotics/stryker-reaches-2-million-mako-cases/)
12. [Stryker launches expensive Mako robot for knee replacement](https://medcitynews.com/2017/03/stryker-launches-expensive-mako-robot-knee-replacement-cost-conscious-era/)
13. [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/)
14. [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)
15. [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)
16. [Stryker reaches robotic surgery milestone](https://www.stryker.com/us/en/about/stryker-news/2024-robotic-assisted-surgery-milestone.html)
17. [Stryker Mako reaches 1,000 installation milestone](https://www.massdevice.com/stryker-mako-smart-robotics-1000-installations/)
18. [Stryker high-growth offense 2025](https://www.orthoworld.com/strykers-high-growth-offense-surges-to-end-2025/)

_Canonical: https://deploy.report/models/mako-smartrobotics_