ROSA

Zimmer Biomet's ROSA (Robotic Surgical Assistant) is a single articulated robotic arm coupled to optical navigation and 2D/3D planning software, and the mid-size, cross-domain archetype of the orthopedic sub-cohort: it spans orthopedics and neurosurgery. The arm positions and guides instruments but moves only on surgeon command; it does not cut or place autonomously (AI-augmented, surgeon-controlled). Current Zimmer Biomet variants are ROSA Knee (total knee arthroplasty, imageless X-Atlas workflow, cleared January 25, 2019; 'ROSA Knee with OptimiZe' cleared November 14, 2025), ROSA Hip (direct-anterior total hip arthroplasty specifically, cleared August 18, 2021), ROSA ONE Brain (cranial neurosurgery: biopsy, SEEG, DBS, and endoscopy, cleared February 11, 2019), and ROSA Shoulder (cleared February 2024). Made by Zimmer Biomet (NYSE: ZBH). Two cap-flags: ROSA Spine is not a current Zimmer Biomet variant (it left in the 2022 ZimVie spinoff), and Zimmer Biomet's autonomy ambitions run through its separate Monogram acquisition, not ROSA. As enterprise B2B surgical equipment, there is no consumer price.

Previous generation

• ROSA on the DEPLOY registry

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

Readiness

ROSA is internal use only (not for retail) at $1,000,000-$1,500,000 (analyst estimate), the 1 capability claim on file is all teleoperated-assisted with claimed, 2 verified deployments are on file, and 1 incident is on record.

Availability

internal-only

Internal use only (not for retail).

see evidence →

Price honesty

analyst-estimate

One price on file: $1,000,000-$1,500,000 (analyst estimate).

see evidence →

Capability honesty

teleoperated-assisted

1 reviewed claim: teleoperated-assisted, claimed.

see evidence →

Real-world use

commercial

Maturity: commercial. 2 verified deployments in the registry.

see evidence →

Safety record

incidents-on-file

1 incident on record across 2 verified deployments.

see evidence →

What it claims to do

• Assists surgeryteleoperated-assisted· claimedevidence ↗

Price

• $1,000,000-$1,500,000analyst estimate · How Much is a Surgical Robot? (2025 Edition) – R2 Surgical ↗ · as of 2025-01-01

Real-world use

• France2020-01-01
• United States2019-01-01

Safety record

• Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory2021-09-22

Privacy

No privacy practices disclosed or on file for ROSA.

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

formFactor

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

What's under the hood

No brain on file for ROSA.

Frequently asked questions

Is the ROSA actually available for purchase?

Not available to consumers. In internal use by Zimmer Biomet.Source: Zimmer Biomet receives FDA clearance for ROSA Knee System (Jan 25 2019; TKA)

What does the ROSA cost?

ROSA costs $1,000,000-$1,500,000 one-time (analyst estimate).Source: How Much is a Surgical Robot? (2025 Edition) – R2 Surgical

Does the ROSA really assists surgery?

Claimed at teleoperator-assisted autonomy; verification status: claimed.Source: ROSA Knee System -- Zimmer Biomet product page; robotic surgical assistant for total knee replacement; pre-operative planning with intraoperative guidance for bone resection and implant alignment

Where is the ROSA being used?

ROSA is in use at: France (2020-01-01) and United States (2019-01-01).Source: ROSA Robotics

Is the ROSA safe?

Incidents on record: 1 (1 recall). See Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory.Source: Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory

How does the ROSA handle privacy?

No privacy practices disclosed or on file for ROSA.

Who makes the ROSA?

ROSA is made by Zimmer Biomet, based in Warsaw, IN.Source: Zimmer Biomet receives FDA clearance for ROSA Knee System (Jan 25 2019; TKA)

Video

Compare side by side

• ROSA vs Hugo RASby Medtronic · surgical

Sources

1. Zimmer Biomet receives FDA clearance for ROSA Knee System (Jan 25 2019; TKA) · https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749 ↗
2. Zimmer Biomet receives FDA clearance for ROSA Hip System (Aug 18 2021; direct anterior THA) · https://investor.zimmerbiomet.com/news-and-events/news/2021/08-18-2021-133112714 ↗
3. ROSA Knee with OptimiZe FDA clearance (Nov 14 2025; US availability Q1 2026) · https://www.prnewswire.com/news-releases/zimmer-biomet-receives-us-fda-clearance-for-enhanced-version-of-rosa-knee-robotic-technology-302615106.html ↗
4. ROSA ONE Brain Application FDA clearance (Feb 11 2019; biopsy, SEEG, DBS, ventricular/transnasal endoscopy) · https://www.meddeviceonline.com/doc/zimmer-biomet-fda-clearance-rosa-one-brain-application-0001 ↗
5. Zimmer Biomet 8-K: Medtech SA acquisition (EUR 50.00/share; completed 2016; ROSA Brain/Spine origin, Montpellier) · https://www.sec.gov/Archives/edgar/data/0001136869/000119312516649891/d223411dex991.htm ↗
6. ROSA for pediatric epilepsy: 23 consecutive SEEG cases, 148 electrodes, no perioperative complications (Children 2020) · https://pmc.ncbi.nlm.nih.gov/articles/PMC7465763/ ↗
7. Zimmer Biomet completes Monogram Technologies acquisition (closed Oct 7 2025; SEPARATE autonomous-robotics line, not ROSA) · https://www.prnewswire.com/news-releases/zimmer-biomet-completes-acquisition-of-monogram-technologies-302577035.html ↗
8. ROSA Hip System · 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 ↗
9. ROSA Knee System -- Zimmer Biomet product page; robotic surgical assistant for total knee replacement; pre-operative planning with intraoperative guidance for bone resection and implant alignment · https://www.zimmerbiomet.com/en/products-and-solutions/specialties/robotics/rosa-knee-system.html ↗
10. How Much is a Surgical Robot? (2025 Edition) – R2 Surgical · https://r2surgical.com/blogs/news/how-much-is-a-surgical-robot-2025-edition ↗
11. ROSA Robotics · https://www.zimmerbiomet.com/en/products-and-solutions/specialties/robotics/rosa-robotics.html ↗
12. Zimmer Biomet Robotics Europe · https://www.zimmerbiomet.eu/en/healthcare-professionals/products-and-solutions/robotics.html ↗
13. ROSA 500,000 procedure milestone · https://medicalsupplierhub.com/news/zimmer-biomet-rosa-knee-robot-500000-procedures-milestone ↗
14. ROSA Knee FDA clearance · https://www.fda.gov/medical-devices/recently-approved-devices/rosa-knee-robotic-assisted-total-knee-replacement-system-k191259 ↗