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)

Manufacturer-attributed media (1)

Manufacturer-supplied media at the model level. Not tied to an independently verified named-site deployment. Verification posture is product-showcase from the maker, distinct from the deployment-verified evidence in the section above.

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 (4)

• K242373fda 510k · us_fdacleared2024-08-09

  Applicant: Stryker

• K241517fda 510k · us_fdacleared2024-05-29

  Applicant: Stryker

• Z-1910-2024fda recall · us_fdarecalled2024-05-28

  Applicant: Stryker

• K072806fda 510k · us_fdacleared2007-10-01

  Applicant: Stryker

Incidents affecting Mako (1)

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

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 ↗

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.

Who makes Mako?

Mako is made by Stryker, based in Portage, Michigan, USA, founded in 1941.

Where is Mako deployed?

No verified deployments of Mako are currently on the DEPLOY registry. DEPLOY records deployments only when verified at a named site with a primary source; absence may reflect pre-deployment, research, or manufacturer-internal use.

What is Mako's maturity stage?

Mako 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.

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