# Mako

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

## Media

- **Video (primary-source)**: [Stryker Mako SmartRobotics](https://www.youtube.com/watch?v=qRezlvYxEw8). 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. 'SmartRobotics' is Stryker's framing. FDA 510(k)-cleared for knee (total and partial) and hip arthroplasty. _(via Stryker)_

_Each clip and image on this page carries a provenance label. [About our media provenance](/consumer#media-provenance)._

## 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

> Mako is internal use only (not for retail), no capability claims are on file, the model has no verified field deployments in the registry, and 1 incident is on record.

## Readiness

- **Availability** (internal-only): Internal use only (not for retail).
- **Price honesty** (no-price): No price points on file for Mako.
- **Capability honesty** (no-claims): No reviewed capability claims on file for Mako.
- **Real-world use** (commercial): Maturity: commercial. No verified deployments in the registry.
- **Safety record** (incidents-on-file): 1 incident on record across 0 verified deployments.

## What it claims to do

_No reviewed capability claims on file._

## Price

_No reviewed price points on file._

## Real-world use

_No verified deployments on file for Mako._

## Safety record

- [Stryker Mako Total Knee software correction over 'error #3' codes when switching applications](/incidents/stryker-mako-software-error-recall-2024), 2024-05-28

## Privacy

_No privacy practices disclosed or on file for Mako._

## Specs

- **notes**: [{"label":"Corporate / acquisition","value":"Stryker (NYSE: SYK) founded 1941 by Dr. Homer H. Stryker, incorporated in Michigan 1946; principal offices Portage, Michigan (NOT Kalamazoo - the founding metro). Acquired MAKO Surgical for ~$1.65B ($30.00/share; announced Sep 25 2013, closed Dec 17 2013); MAKO's product was the RIO Robotic Arm Interactive Orthopedic System (then cleared for partial knee + total hip)."},{"label":"AI-as-primary boundary (the cohort's editorial point)","value":"AI-AUGMENTED, SURGEON-CONTROLLED assistance - NOT autonomous surgery. Software does CT planning, real-time bone tracking, and haptic boundary enforcement (stops the tool at the plan boundary); the surgeon guides the arm and makes all cuts. Same assistive class as Intuitive da Vinci; in-scope as a surgical robot."},{"label":"Verified scale (SEC, FY2024 10-K)","value":">1 million robotic Mako Total Knees and 1.5 million total Mako procedures performed globally (cumulative) across hips/knees; sold in 45+ countries. Stryker describes itself as 'one of four leading global competitors' (with Zimmer Biomet, J&J MedTech, Smith+Nephew) - it does NOT self-assert a market-share % in the 10-K."},{"label":"Cap-flag (aggregator drift)","value":"No installed-base system count appears in the FY2024 10-K - any 'thousands of systems' or specific market-share % is aggregator/analyst-sourced; do not assert. Spine + Shoulder 510(k)s ARE cleared (K241517 / K242373); 2025/2026 'coming' framing in trade coverage refers to commercial rollout, not regulatory status. The hip-revision 'first FDA-authorized revision feature' (Mar 2025) is trade-press, not SEC-verified."},{"label":"Sub-cohort triangle (orthopedic, within surgical)","value":"Large-footprint commercial-market-leader archetype with the broadest multi-procedure clearance (knee/hip/spine/shoulder). The orthopedic triangle: Mako (large-footprint, CT-based, broad scope) vs Smith+Nephew CORI (handheld, imageless, knee) vs Zimmer Biomet ROSA (mid-size, knee/hip/brain). Form-factor + procedure-scope + parent-company variance across three public (SEC-disclosed) makers."}]
- **specs**: Mako (Mako SmartRobotics): surgeon-guided robotic arm for orthopedic joint replacement. CT-based 3D pre-op planning + intra-op HAPTIC BOUNDARY CONTROL (AccuStop: physically constrains the saw/burr to the planned resection zone) + real-time optical bone tracking. The surgeon holds/guides the arm and makes every cut; the robot does not move or cut autonomously. Cleared procedures: partial/unicompartmental knee, total knee (Aug 2015), cementless total knee, total hip, a hip-revision feature, Mako Spine (510(k) K241517, May 2024; non-cervical pedicle-screw placement via the Q Guidance System), and Mako Shoulder 1.0 (510(k) K242373, Nov 2024; reverse shoulder arthroplasty). Sold in 45+ countries. Made by Stryker (NYSE: SYK).
- **formFactor**: surgical (robotic-arm-assisted orthopedic joint replacement; surgeon-controlled + AI-augmented, NOT autonomous; large-footprint CT-based)

## What's under the hood

_No brain on file for Mako._

## Frequently asked questions

### Is the Mako 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 Mako cost?

Not announced.

### Where is the Mako being used?

No verified field deployments on record.

### Is the Mako safe?

Incidents on record: 1 (1 recall). See Stryker Mako Total Knee software correction over 'error #3' codes when switching applications.

_Source: [Stryker Mako Total Knee software correction over 'error #3' codes when switching applications](/incidents/stryker-mako-software-error-recall-2024)._

### How does the Mako handle privacy?

No privacy practices disclosed or on file for Mako.

### Who makes the Mako?

Mako is made by Stryker, based in Portage, Michigan, 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 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)
2. [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)
3. [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)
4. [Mako Spine System 510(k) K241517 (decision May 29 2024; non-cervical pedicle-screw placement)](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241517.pdf)
5. [Mako Shoulder Application 1.0 510(k) K242373 (Nov 7 2024; reverse shoulder arthroplasty)](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K242373)
6. [Robotic-assisted TKA with Mako: systematic review and meta-analysis (2025; better medium-term function, more RCTs urged)](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12588732/)
7. [Mako SmartRobotics overview (CT-based planning + AccuStop haptic boundary + bone tracking)](https://www.stryker.com/us/en/joint-replacement/systems/Mako_SmartRobotics_Overview.html)
8. [Stryker official YouTube (@stryker), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06.](https://www.youtube.com/watch?v=qRezlvYxEw8) · 2026-06-04

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