DEPLOYDatabase

Robot model

Stryker Mako SmartRobotics

surgicalcommercialby Stryker

Robotic arm for knee and hip replacement surgery.

Track Stryker Mako SmartRobotics
Manufacturer
Stryker
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
8
Website
stryker.com ↗

The verified answer

As of Sep 2026, DEPLOY verifies Stryker Mako SmartRobotics, a surgical by Stryker (commercial): 8 verified deployments on record. 1 source back the record.

Regulatory status4 FDA 510(k) clearances1 FDA recall

Stryker Mako SmartRobotics holds 4 FDA 510(k) clearances and has 1 FDA recall on record, per the DEPLOY registry.

See all 5 filings

Overview

Robotic arm for knee and hip replacement surgery. AccuStop haptic feedback and patient-specific planning.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

Product

Mako SmartRobotics robotic-arm orthopedic system (knee/hip/spine/shoulder).

Boundary

AI-augmented surgeon-controlled assistance, NOT autonomous.

Stock ticker

NYSE: SYK

Market position

Mako SmartRobotics is the market-leading robotic-arm system for orthopedic joint replacement

Acquisition

Acquired MAKO Surgical in 2013 for ~$1.65B

CEO

Kevin Lobo (Chair & CEO)

Revenue

$25B (2025)

Stock

NYSE: SYK

Employees

approximately 56,000

Robotics platform

Mako SmartRobotics (hip, knee, shoulder)

Data & sources

Web sources

1

1 source 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

One-time purchase

$1,000,000 - $1,500,000 USDactual sale priceas of 2023-01-01

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.

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 (8)

Free to use on your site, with a link back to DEPLOY.

Stryker Mako SmartRobotics on the deployment map

View the global map

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

Free to use on your site, with a link back to DEPLOY.

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

6 recalls and 3 incidents on record (7 serious, 2 moderate). Most recent: Apr 2025.

serious
7
moderate
2
recall
6
malfunction
2
injury
1

Most recent: Apr 2025

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

Incidents affecting Stryker Mako SmartRobotics (9)

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 (1)

  1. https://www.stryker.com/

Compare Stryker Mako SmartRobotics

Common questions

What is Stryker Mako SmartRobotics?
Robotic arm for knee and hip replacement surgery. AccuStop haptic feedback and patient-specific planning.
How much does Stryker Mako SmartRobotics cost?
Stryker Mako SmartRobotics is listed at $1,000,000 to $1,500,000 on the DEPLOY registry. This is an actual sale price on record.
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.
Is Stryker Mako SmartRobotics actually deployed in the real world?
Yes. Stryker Mako SmartRobotics 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 Stryker Mako SmartRobotics autonomous or teleoperated?
Not verified as fully autonomous. Stryker Mako SmartRobotics'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 Stryker Mako SmartRobotics?
Stryker Mako SmartRobotics is made by Stryker, based in Kalamazoo, MI, USA, founded in 1941.
Where is Stryker Mako SmartRobotics deployed?
8 verified deployments of Stryker Mako SmartRobotics are on the DEPLOY registry, including at United States (multiple hotel chains), Ireland, Germany.
Can you buy Stryker Mako SmartRobotics?
Stryker Mako SmartRobotics is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).
Is Stryker Mako SmartRobotics FDA cleared?
Stryker Mako SmartRobotics has 5 regulatory records on the DEPLOY registry: FDA 510(k) clearance (K242373), cleared; FDA 510(k) clearance (K241517), cleared; FDA recall (Z-1910-2024), recalled and 2 more. See the Regulatory filings section for each agency source.
What are alternatives to Stryker Mako SmartRobotics?
On the DEPLOY registry, comparable surgical robots to Stryker Mako SmartRobotics include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Toumai.
How does Stryker Mako SmartRobotics compare to da Vinci (and Ion)?
Stryker Mako SmartRobotics and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Stryker Mako SmartRobotics has 8 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is Stryker Mako SmartRobotics a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Stryker Mako SmartRobotics ranks in roughly the top 14% of surgical models tracked by the registry.
What is Stryker Mako SmartRobotics's maturity stage?
Stryker Mako SmartRobotics is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.
Is Stryker Mako SmartRobotics safe?
Stryker Mako SmartRobotics has 9 active incidents on record in the DEPLOY registry. 6 recalls and 3 incidents on record (7 serious, 2 moderate). Most recent: Apr 2025. Retracted incidents are excluded from this count.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-07-12

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-12

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

1
unclassified
Unclassified source

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

Methodology surface for Stryker Mako SmartRobotics.

Recent coverage

Stryker Mako SmartRobotics in third-party press

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Jul 9, 2026

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Jun 19, 2026

Stryker Debuts Handheld Mako Robotic Preparation System

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