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Robot model

ROSA

surgicalcommercialby Zimmer Biomet

ROSA, the Robotic Surgical Assistant, is Zimmer Biomet's surgeon-controlled robotic-arm platform, recorded in the surgical form factor as the mid-size,…

Track ROSA
Manufacturer
Zimmer Biomet
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
2
Website
investor.zimmerbiomet.com ↗

The verified answer

As of Oct 2026, DEPLOY verifies ROSA, a surgical by Zimmer Biomet (commercial): 2 verified deployments on record. 8 sources back the record.

Regulatory status2 FDA 510(k) clearances1 FDA recall

ROSA holds 2 FDA 510(k) clearances and has 1 FDA recall on record, per the DEPLOY registry.

See all 3 filings

Overview

ROSA, the Robotic Surgical Assistant, is Zimmer Biomet's surgeon-controlled robotic-arm platform, recorded in the surgical form factor as the mid-size, multi-procedure archetype of the orthopedic sub-cohort and the one that crosses surgical sub-domains, spanning orthopedics and neurosurgery from a single robotic-arm and navigation architecture. The arm is coupled to optical navigation and two- and three-dimensional planning software and positions or guides instruments, but it moves only on surgeon command and does not cut or place autonomously, so ROSA is AI-augmented surgeon-controlled assistance rather than autonomous surgery and is in scope as a surgical robot.

Made by Zimmer Biomet Holdings, listed on the New York Stock Exchange as ZBH and headquartered in Warsaw, Indiana, ROSA originated at the French company Medtech SA, founded in 2002 in Montpellier by Bertin Nahum, which built ROSA Brain and ROSA Spine; Zimmer Biomet acquired Medtech SA in 2016 at fifty euros per share and extended the ROSA arm into orthopedics. The current Zimmer Biomet variants are ROSA Knee for total knee arthroplasty, cleared January 25, 2019 and enhanced as ROSA Knee with OptimiZe cleared November 14, 2025, ROSA Hip for direct anterior total hip arthroplasty cleared August 18, 2021, ROSA ONE Brain for cranial neurosurgery including biopsy, stereo-electro-encephalography, deep brain stimulation, and ventricular and transnasal endoscopy cleared February 11, 2019, and ROSA Shoulder for shoulder arthroplasty cleared in February 2024.

ROSA ONE Spine, cleared in 2019, left Zimmer Biomet in the March 2022 ZimVie spinoff and is no longer a Zimmer Biomet product. A registry nuance worth recording is that autonomy enters Zimmer Biomet's portfolio separately through its Monogram Technologies acquisition, completed October 7, 2025, which brings a CT-based semi-autonomous total-knee robot and a fully-autonomous version in development; this is kept distinct from ROSA, whose surgeon-controlled status is unchanged. Installed-base figures circulating in aggregators conflict and none is asserted here.

Verified vs. claimed

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

Key facts

Autonomy level

Surgeon-controlled, AI-augmented; arm moves only on surgeon command and does not cut or place autonomously

Drive type

Single articulated robotic arm coupled to optical navigation and 2D/3D planning software

Form factor

Surgical, mid-size, multi-procedure platform spanning orthopedics and neurosurgery

ROSA Knee clearance date

January 25, 2019

ROSA Hip clearance date

August 18, 2021

Price

$700,000-$1,500,000 (ROSA Knee)

Availability

Commercial — hospital capital purchase, Zimmer Biomet sales

Pricing model

Hospital capital equipment purchase

Specs

Arms

single articulated robotic arm

Notes

Corporate / lineage (verified): Zimmer Biomet Holdings (NYSE: ZBH; HQ Warsaw, Indiana; spun off 2001, acquired Biomet + renamed 2015). ROSA originated at Medtech SA (founded 2002, Montpellier, France; founder Bertin Nahum), which built ROSA Brain + ROSA Spine; Zimmer Biomet acquired Medtech SA in 2016 (EUR 50.00/share; completed July 2016) and extended the ROSA arm into orthopedics (Knee 2019, Hip 2021, Shoulder 2024). Montpellier remains ZB's surgical-robotics center of excellence., AI-as-primary boundary (the cohort's editorial point): AI-AUGMENTED, SURGEON-CONTROLLED assistance across orthopedics AND neurosurgery - NOT autonomous (the arm moves only on surgeon command). In-scope as a surgical robot. NUANCE: autonomy enters Zimmer Biomet's portfolio SEPARATELY via the Monogram Technologies acquisition (closed Oct 7 2025; a CT-based semi-autonomous TKA robot + a fully-autonomous version in development) - keep Monogram distinct from ROSA; the ROSA verdict (surgeon-controlled) is unchanged., ROSA Spine departed (correction): ROSA ONE Spine was cleared (Mar 2019) but LEFT Zimmer Biomet in the ZimVie spinoff (Mar 1 2022) and is NO LONGER a ZB product (ZimVie later exited spine entirely). The current ZB ROSA lineup is Knee, Hip, Brain, Shoulder - do NOT list Spine as a ZB ROSA variant., Cap-flag (aggregator drift): Installed-base figures conflict wildly across aggregators ('approaching 2,000' vs 'over 1,000 by end-2025' vs 'surpassed 500') - none traced to a ZB IR/8-K this pass; do NOT assert a number. The recurring 'ROSA Brain 120 hospitals / >9,000 procedures' is dated Medtech-era marketing, not a current verified figure. 510(k) K-numbers were not retrieved (clearance DATES anchored to ZB IR / trade press). ROSA Hip's cleared indication is specifically DIRECT ANTERIOR THA, narrower than the aggregator 'total hip' phrasing., Sub-cohort triangle (orthopedic, within surgical): Mid-size, multi-procedure platform archetype crossing surgical sub-domains (orthopedics + neurosurgery) - demonstrates cross-domain platform extension from a single robotic-arm + navigation architecture. Orthopedic triangle: Mako (large-footprint, CT-based, broad ortho scope) vs Smith+Nephew CORI (handheld, imageless, knee) vs ROSA (mid-size, knee/hip/brain).

Specs

ROSA (Robotic Surgical Assistant): a single articulated robotic arm coupled to optical navigation and 2D/3D planning software; the arm positions/guides instruments but moves only on surgeon command (it does not cut or place autonomously). Current Zimmer Biomet variants: ROSA Knee (TKA; imageless X-Atlas 2D-to-3D workflow with the Persona Knee; cleared Jan 25 2019; 'ROSA Knee with OptimiZe' cleared Nov 14 2025), ROSA Hip (direct anterior THA specifically; cleared Aug 18 2021), ROSA ONE Brain (cranial neurosurgery: biopsy, SEEG, DBS, ventricular/transnasal endoscopy; cleared Feb 11 2019), and ROSA Shoulder (shoulder arthroplasty; cleared Feb 2024). Made by Zimmer Biomet (NYSE: ZBH).

Weight kg

460

Form Factor

surgical (MULTI-PROCEDURE robotic surgical assistant spanning orthopedics + neurosurgery; surgeon-controlled + AI-augmented, NOT autonomous; mid-size arm)

Fda clearance

ROSA Knee Jan 25 2019; ROSA Knee with OptimiZe Nov 14 2025; ROSA Hip Aug 18 2021; ROSA ONE Brain Feb 11 2019; ROSA Shoulder Feb 2024

Visualization

optical navigation and 2D/3D planning software

Procedure types

total knee arthroplasty, direct anterior total hip arthroplasty, cranial neurosurgery, shoulder arthroplasty

Data & sources

Company filings

1

Press releases

3

Research

1

Web sources

3

8 sources backing this record.View all →

Availability and pricing

Availability
Not sold (internal use)
Price
$1M to $1.5M (analyst estimate)as of 2025-01-01
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$1,000,000 - $1,500,000 USDanalyst estimateas of 2025-01-01

Source: How Much is a Surgical Robot? (2025 Edition) – R2 Surgical

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, 2025

Deployments (2)

  • ROSA at Franceoperational

    ROSA surgical systems have approximately 100 or more installations across Europe, with an active CE mark covering ROSA Knee and Hip applications.

  • ROSA at United Statesoperational

    ROSA surgical robots have been installed across approximately 500+ systems in the United States, with FDA clearances for knee (2019), hip (2021), and shoulder (2024) replacement procedures.

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

ROSA on the deployment map

View the global map

Where ROSA 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.

  • Incident recordedJun 15, 2026

    FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly

  • Verified media addedVerifiedJun 5, 2026

    Zimmer Biomet ROSA Knee System

  • Record createdJun 4, 2026

    Added to the verified registry

  • Incident recordedApr 1, 2026

    Zimmer ROSA Recon: force sensor error and unintended robotic-arm drift during a knee case...

  • Incident recordedMar 9, 2026

    Zimmer ROSA Recon: a large amount of sparks with a hole found in the power cord (FDA...

Full change history →

Previous generation

The historical entries remain on the registry for reference; current coverage tracks this generation.

Deployment-verified media (1)

PRIMARY SOURCE
Courtesy of Zimmer Biomet

Zimmer Biomet's patient explainer for its ROSA Knee system (the knee variant, for total knee arthroplasty). A surgeon-controlled robotic assistant for bone-cut guidance, not autonomous.

From deployment: United States

Components (1)

  • ROSA ONE Brain Navigation Systemcontrol systemsafety-critical(primary safety)

    Navigation / trajectory control

    • software fault · critical: FDA Class I recall; software correction for trajectory error.

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

Regulatory filings (3)

Safety record

12 recalls and 3 incidents on record (1 catastrophic, 2 critical, 12 serious). Most recent: Jun 2026.

catastrophic
1
critical
2
serious
12
recall
12
malfunction
2
injury
1

Most recent: Jun 2026

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

Incidents affecting ROSA (15)

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 (8)

  1. https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749
  2. https://investor.zimmerbiomet.com/news-and-events/news/2021/08-18-2021-133112714
  3. https://www.prnewswire.com/news-releases/zimmer-biomet-receives-us-fda-clearance-for-enhanced-version-of-rosa-knee-robotic-technology-302615106.html
  4. https://www.meddeviceonline.com/doc/zimmer-biomet-fda-clearance-rosa-one-brain-application-0001
  5. https://www.sec.gov/Archives/edgar/data/0001136869/000119312516649891/d223411dex991.htm
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC7465763/
  7. https://www.prnewswire.com/news-releases/zimmer-biomet-completes-acquisition-of-monogram-technologies-302577035.html
  8. https://www.zimmerbiomet.com/content/dam/zb-corporate/en/products/smart-orthopedics/robotics/rosa-hip-system/3500.6-GLBL-en%20ROSA%20Hip%20System%20User%20Manual%20and%20Surg%20Tech%20V1.1-digital.pdf

Compare ROSA

Common questions

What is ROSA?
ROSA, the Robotic Surgical Assistant, is Zimmer Biomet's surgeon-controlled robotic-arm platform, recorded in the surgical form factor as the mid-size, multi-procedure archetype of the orthopedic sub-cohort and the one that crosses surgical sub-domains, spanning orthopedics and neurosurgery from a single robotic-arm and navigation architecture. The arm is coupled to optical navigation and two- and three-dimensional planning software and positions or guides instruments, but it moves only on surgeon command and does not cut or place autonomously, so ROSA is AI-augmented surgeon-controlled assistance rather than autonomous surgery and is in scope as a surgical robot. Made by Zimmer Biomet Holdings, listed on the New York Stock Exchange as ZBH and headquartered in Warsaw, Indiana, ROSA originated at the French company Medtech SA, founded in 2002 in Montpellier by Bertin Nahum, which built ROSA Brain and ROSA Spine; Zimmer Biomet acquired Medtech SA in 2016 at fifty euros per share and extended the ROSA arm into orthopedics. The current Zimmer Biomet variants are ROSA Knee for total knee arthroplasty, cleared January 25, 2019 and enhanced as ROSA Knee with OptimiZe cleared November 14, 2025, ROSA Hip for direct anterior total hip arthroplasty cleared August 18, 2021, ROSA ONE Brain for cranial neurosurgery including biopsy, stereo-electro-encephalography, deep brain stimulation, and ventricular and transnasal endoscopy cleared February 11, 2019, and ROSA Shoulder for shoulder arthroplasty cleared in February 2024. ROSA ONE Spine, cleared in 2019, left Zimmer Biomet in the March 2022 ZimVie spinoff and is no longer a Zimmer Biomet product. A registry nuance worth recording is that autonomy enters Zimmer Biomet's portfolio separately through its Monogram Technologies acquisition, completed October 7, 2025, which brings a CT-based semi-autonomous total-knee robot and a fully-autonomous version in development; this is kept distinct from ROSA, whose surgeon-controlled status is unchanged. Installed-base figures circulating in aggregators conflict and none is asserted here.
How much does ROSA cost?
ROSA is listed at $1,000,000 to $1,500,000 on the DEPLOY registry. This is an analyst estimate, not an official price.
How Much is a Surgical Robot? (2025 Edition) – R2 Surgical
Is ROSA actually deployed in the real world?
Yes. ROSA 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 ROSA autonomous or teleoperated?
Not verified as fully autonomous. ROSA'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.
Where is ROSA deployed?
2 verified deployments of ROSA are on the DEPLOY registry, including at France, United States.
Can you buy ROSA?
ROSA is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.
Is ROSA FDA cleared?
ROSA has 3 regulatory records on the DEPLOY registry: FDA recall, recalled; FDA 510(k) clearance, cleared; FDA 510(k) clearance (K182964), cleared. See the Regulatory filings section for each agency source.
What are alternatives to ROSA?
On the DEPLOY registry, comparable surgical robots to ROSA include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.
How does ROSA compare to da Vinci (and Ion)?
ROSA and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. ROSA has 2 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is ROSA a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, ROSA ranks in roughly the top 70% of surgical models tracked by the registry.
What is ROSA's maturity stage?
ROSA 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 ROSA safe?
ROSA has 15 active incidents on record in the DEPLOY registry. 12 recalls and 3 incidents on record (1 catastrophic, 2 critical, 12 serious). Most recent: Jun 2026. Retracted incidents are excluded from this count.
How does ROSA compare to Stryker Mako for knee replacement?
Neither Mako nor ROSA is clearly superior, according to industry analysts. Mako features a robotic arm with a bone saw and emphasizes haptic feedback. ROSA uses a cutting guide approach. Both are FDA-cleared for robotic-assisted knee replacement. Mako has over 1 million completed procedures; ROSA has multiple indications (knee, hip, brain, shoulder) with a Class I recall on the brain version.
DocWire: Mako vs ROSA R2Surgical: ROSA vs Mako comparison
Methodology: Aggregator drift detected · 8 sources (5 primary) · last reviewed 2026-07-15

Verification posture

Aggregator drift detected

Cap-flag required

Review state

Drift-flagged

Last reviewed 2026-07-15

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
3
unclassified
Unclassified source
1
primary-sec-filing
SEC filing
1
primary-academic-peer-reviewed
Peer-reviewed clinical / academic

Canonical worked example pair

Surgical orthopedic robot sub-cohort triangle

This entity is the knee-only post-ZimVie-spin-off anchor on within-cohort-verified-vs-claimed-pair.

Pairs with: stryker-mako, smith-nephew-cori

Cap flags

  • Claim: Zimmer Biomet ROSA Spine is a current ROSA variant

    Honest status: ROSA Spine left Zimmer Biomet in the 2022 ZimVie spin-off and is not a current ZB ROSA variant. Current ZB ROSA scope is knee + hip; spine moved with ZimVie.

    ROSA Spine departed Zimmer Biomet via 2022 ZimVie spin-off. Current ZB ROSA is knee + hip only.

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

Methodology surface for ROSA.

Recent coverage

ROSA in third-party press

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Oct 5, 2026

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Oct 5, 2026