DEPLOYDatabase

Robot model

Mako

Mako (marketed as Mako SmartRobotics) is Stryker's surgeon-guided robotic-arm system for orthopedic joint replacement, recorded in the surgical form factor as…

Manufacturer
Stryker
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
2

Overview

Mako (marketed as Mako SmartRobotics) is Stryker's surgeon-guided robotic-arm system for orthopedic joint replacement, recorded in the surgical form factor as the large-footprint, CT-based commercial-market-leader archetype of the orthopedic sub-cohort. It pairs CT-based three-dimensional pre-operative planning with intra-operative haptic boundary control, branded AccuStop, that physically constrains the saw or burr to the planned resection zone, and real-time optical bone tracking that keeps that boundary registered to the patient; the surgeon holds and guides the arm and makes every cut, so the system is AI-augmented surgeon-controlled assistance and not autonomous surgery, the same assistive class as Intuitive's da Vinci. Made by Stryker, listed on the New York Stock Exchange as SYK, founded in 1941 by Dr. Homer H. Stryker, incorporated in Michigan in 1946 and headquartered in Portage, Michigan, the platform entered Stryker through its roughly 1.65 billion dollar acquisition of MAKO Surgical at thirty dollars per share, announced September 25, 2013 and closed December 17, 2013, when MAKO's product was the RIO system cleared for partial knee and total hip. Its FDA-cleared scope has since broadened to partial and total knee, cementless total knee, total hip, a hip-revision feature, the Mako Spine System for non-cervical pedicle-screw placement cleared under 510(k) K241517 in May 2024, and the Mako Shoulder application for reverse shoulder arthroplasty cleared under 510(k) K242373 in November 2024. Per Stryker's FY2024 10-K the system is sold in more than forty-five countries with more than one million robotic Mako Total Knees and 1.5 million total Mako procedures performed cumulatively, and Stryker describes itself as one of four leading global competitors rather than asserting a specific market share; no installed-base system count appears in the 10-K, so any thousands-of-systems or market-share figure is aggregator-sourced and is not asserted here.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Verified deployments
2 deployments on file
Sources on file
7 sources, view all

Key facts

Autonomy level

AI-augmented, surgeon-controlled assistance (not autonomous)

Form factor

Large-footprint, CT-based robotic-arm system for orthopedic joint replacement

Acquisition price

~$1.65 billion ($30.00 per share)

Countries sold in

45+ countries

Cumulative procedures

>1 million Mako Total Knees and 1.5 million total Mako procedures performed globally

FDA clearance

510(k) K241517 — Mako Spine System for non-cervical pedicle-screw placement, cleared May 2024

FDA clearance

510(k) K242373 — Mako Shoulder application for reverse shoulder arthroplasty, cleared November 2024

Price

$800,000-$1,400,000 (Mako 4 next-gen)

Availability

Commercial — hospital capital purchase, Stryker sales

Pricing model

Hospital capital equipment purchase

Specs

Notes

Corporate / acquisition: 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)., AI-as-primary boundary (the cohort's editorial point): 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., Verified scale (SEC, FY2024 10-K): >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., Cap-flag (aggregator drift): 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., Sub-cohort triangle (orthopedic, within surgical): 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).

Form Factor

surgical (robotic-arm-assisted orthopedic joint replacement; surgeon-controlled + AI-augmented, NOT autonomous; large-footprint CT-based)

Fda clearance

510(k) K241517, 510(k) K242373

Visualization

CT-based three-dimensional pre-operative planning, real-time optical bone tracking

Clearance body

FDA

Procedure types

partial and total knee, cementless total knee, total hip, a hip-revision feature, non-cervical pedicle-screw placement, reverse shoulder arthroplasty

Data & sources

Company filings

1

Press releases

3

Government records

1

Research

1

Web sources

1

7 sources backing this record.View all →

Availability and pricing

Availability
Not sold (internal use)
Price
$1M to $1.5M (actual sale price)as of 2023-01-01
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.

Prices verified as of Jan 1, 2023

Deployments (2)

  • Mako robotic-arm assisted surgical systems have been installed at approximately 50 or more sites across the United Kingdom, with CE mark active for knee and hip procedures.

  • Mako systems have surpassed approximately 1,000 installations globally, with over 1.5 million cumulative procedures performed across knee, hip, and partial knee indications.

Mako on the deployment map

Where Mako is verified operating. Explore the deployment map by place and type.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (1)

PRIMARY SOURCE
Courtesy of Stryker

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.

From deployment: United States

Components (1)

  • Stryker Mako Robotic Arm (RIO)control systemsafety-critical(primary safety)

    Robotic arm / control system

    • software fault · moderate: Field-safety notice; software update for the identified error.

Components carry componentClass + safetyCritical flag. ModelComponent rows carry safety_role (primary_safety / backup_safety / monitoring / non_safety) + optional supplier identity.

Regulatory filings (5)

Safety record

2 recalls on record (1 moderate). Most recent: May 2024.

moderate
1
Severity not classified
1

Most recent: May 2024

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Mako (2)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (7)

  1. https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx
  2. https://www.sec.gov/Archives/edgar/data/0000310764/000031076426000010/syk-20251231.htm
  3. https://investors.stryker.com/press-releases/news-details/2015/Stryker-Receives-FDA-Clearance-For-Mako-Total-Knee-Application/default.aspx
  4. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241517.pdf
  5. https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OLO/K242373
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12588732/
  7. https://www.stryker.com/us/en/joint-replacement/systems/Mako_SmartRobotics_Overview.html

Compare Mako

Common questions

What is Mako?
Mako (marketed as Mako SmartRobotics) is Stryker's surgeon-guided robotic-arm system for orthopedic joint replacement, recorded in the surgical form factor as the large-footprint, CT-based commercial-market-leader archetype of the orthopedic sub-cohort. It pairs CT-based three-dimensional pre-operative planning with intra-operative haptic boundary control, branded AccuStop, that physically constrains the saw or burr to the planned resection zone, and real-time optical bone tracking that keeps that boundary registered to the patient; the surgeon holds and guides the arm and makes every cut, so the system is AI-augmented surgeon-controlled assistance and not autonomous surgery, the same assistive class as Intuitive's da Vinci. Made by Stryker, listed on the New York Stock Exchange as SYK, founded in 1941 by Dr. Homer H. Stryker, incorporated in Michigan in 1946 and headquartered in Portage, Michigan, the platform entered Stryker through its roughly 1.65 billion dollar acquisition of MAKO Surgical at thirty dollars per share, announced September 25, 2013 and closed December 17, 2013, when MAKO's product was the RIO system cleared for partial knee and total hip. Its FDA-cleared scope has since broadened to partial and total knee, cementless total knee, total hip, a hip-revision feature, the Mako Spine System for non-cervical pedicle-screw placement cleared under 510(k) K241517 in May 2024, and the Mako Shoulder application for reverse shoulder arthroplasty cleared under 510(k) K242373 in November 2024. Per Stryker's FY2024 10-K the system is sold in more than forty-five countries with more than one million robotic Mako Total Knees and 1.5 million total Mako procedures performed cumulatively, and Stryker describes itself as one of four leading global competitors rather than asserting a specific market share; no installed-base system count appears in the 10-K, so any thousands-of-systems or market-share figure is aggregator-sourced and is not asserted here.
Is Mako actually deployed in the real world?
Yes. Mako is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Is Mako autonomous or teleoperated?
Not verified as fully autonomous. Mako's capabilities on the DEPLOY registry are recorded as teleoperated-assisted, demonstrated-only, or vendor claims (Assists surgery), not independently confirmed to run without a human in the loop.
Who makes Mako?
Mako is made by Stryker, based in Kalamazoo, MI, USA, founded in 1941.
Methodology: Aggregator drift detected · 7 sources (6 primary) · last reviewed 2026-07-12

Verification posture

Aggregator drift detected

Cap-flag required

Review state

Drift-flagged

Last reviewed 2026-07-12

1 anchored drift pattern(s); see cap_flags

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

3
primary-company-ir
Company IR disclosure
1
primary-sec-filing
SEC filing
1
primary-fda-database
FDA database
1
unclassified
Unclassified source
1
primary-academic-peer-reviewed
Peer-reviewed clinical / academic

Canonical worked example pair

Surgical orthopedic robot sub-cohort triangle

This entity is the knee+hip+spine triple-clearance anchor on within-cohort-verified-vs-claimed-pair.

Pairs with: smith-nephew-cori, zimmer-biomet-rosa

Cap flags

  • Claim: Stryker Mako headquartered in Kalamazoo MI

    Honest status: Stryker is headquartered in Portage MI, not Kalamazoo. Kalamazoo is the adjacent city and the conflation is common in aggregator content.

    Stryker HQ is Portage MI, not Kalamazoo.

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Mako.

Recent coverage

Mako in third-party press