Mako

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

Mako 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, 2 verified deployments are on file, and 1 incident is on record.

Availability

internal-only

Internal use only (not for retail).

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Price honesty

actual-sale-price

One price on file: $1,000,000-$1,500,000 (actual sale price).

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Capability honesty

teleoperated-assisted

1 reviewed claim: teleoperated-assisted, verified.

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Real-world use

commercial

Maturity: commercial. 2 verified deployments in the registry.

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Safety record

incidents-on-file

1 incident on record across 2 verified deployments.

see evidence →

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

• United Kingdom2017-01-01
• United States2006-01-01

Safety record

• Stryker Mako Total Knee software correction over 'error #3' codes when switching applications2024-05-28

Privacy

No privacy practices disclosed or on file for Mako.

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).

formFactor

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

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)

What does the Mako cost?

Mako 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.

Does the Mako 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, Stryker Mako investor materials; Mako installed in >1,000 hospitals globally; cumulative procedures surpassed 500,000 as of 2022

Where is the Mako being used?

Mako is in use at: United Kingdom (2017-01-01) and United States (2006-01-01).Source: Mako robotic-arm assisted surgery UK

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

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 Kalamazoo, MI, USA.Source: Stryker to acquire MAKO Surgical for $1.65B ($30/share; announced Sep 25 2013, closed Dec 17 2013)

Video

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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. 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 ↗
9. 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 ↗
10. Mako robotic-arm assisted surgery UK · https://www.stryker.com/gb/en/healthcare-professionals/products/orthopaedics/robotic-arm-assisted-surgery.html ↗
11. NHS expands robotic surgery with Stryker Mako · https://www.bbc.com/news/health-68765432 ↗
12. Stryker reaches 2 million Mako cases · https://www.beckersspine.com/robotics/stryker-reaches-2-million-mako-cases/ ↗
13. Stryker reaches robotic surgery milestone · https://www.stryker.com/us/en/about/stryker-news/2024-robotic-assisted-surgery-milestone.html ↗
14. Stryker Mako reaches 1,000 installation milestone · https://www.massdevice.com/stryker-mako-smart-robotics-1000-installations/ ↗
15. Stryker high-growth offense 2025 · https://www.orthoworld.com/strykers-high-growth-offense-surges-to-end-2025/ ↗