# ROSA

Manufacturer: [Zimmer Biomet](/companies/zimmer-biomet)  
Category: surgical

## Media

- **Video (primary-source)**: [Zimmer Biomet ROSA Knee System](https://www.youtube.com/watch?v=Gqdo8yFeN0o). 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. FDA 510(k)-cleared. ROSA Brain and ROSA ONE are separately cleared for neurosurgical and spinal use; do not cross-attribute their clearances. _(via Zimmer Biomet)_

_Each clip and image on this page carries a provenance label. [About our media provenance](/consumer#media-provenance)._

## Summary

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.

## Top line

> ROSA is internal use only (not for retail), no capability claims are on file, the model has no verified field deployments in the registry, and 1 incident is on record.

## Readiness

- **Availability** (internal-only): Internal use only (not for retail).
- **Price honesty** (no-price): No price points on file for ROSA.
- **Capability honesty** (no-claims): No reviewed capability claims on file for ROSA.
- **Real-world use** (commercial): Maturity: commercial. No verified deployments in the registry.
- **Safety record** (incidents-on-file): 1 incident on record across 0 verified deployments.

## What it claims to do

_No reviewed capability claims on file._

## Price

_No reviewed price points on file._

## Real-world use

_No verified deployments on file for ROSA._

## Safety record

- [Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory](/incidents/rosa-one-brain-trajectory-recall-2021), 2021-09-22

## Privacy

_No privacy practices disclosed or on file for ROSA._

## Specs

- **notes**: [{"label":"Corporate / lineage (verified)","value":"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."},{"label":"AI-as-primary boundary (the cohort's editorial point)","value":"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."},{"label":"ROSA Spine departed (correction)","value":"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."},{"label":"Cap-flag (aggregator drift)","value":"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."},{"label":"Sub-cohort triangle (orthopedic, within surgical)","value":"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).
- **formFactor**: surgical (MULTI-PROCEDURE robotic surgical assistant spanning orthopedics + neurosurgery; surgeon-controlled + AI-augmented, NOT autonomous; mid-size arm)

## 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)](https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749)._

### What does the ROSA cost?

Not announced.

### Where is the ROSA being used?

No verified field deployments on record.

### 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](/incidents/rosa-one-brain-trajectory-recall-2021)._

### 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, Indiana, USA.

_Source: [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)._

## Manufacturer

- [Zimmer Biomet (https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749)](https://investor.zimmerbiomet.com/news-and-events/news/2019/01-25-2019-140357749)

## Compared to

- [Hugo RAS](/consumer/models/medtronic-hugo)

## 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. [Zimmer Biomet official YouTube (@ZimmerBiomet), embedded under standard YouTube embed terms. oEmbed author_url verified 2026-06.](https://www.youtube.com/watch?v=Gqdo8yFeN0o) · 2026-06-04

_Canonical: https://deploy.report/models/zimmer-biomet-rosa_