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)

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)

• 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 (2)

• fda_recallfda recall · us_fdarecalled2021-09-22

  Applicant: Zimmer Biomet

• K182964fda 510k · us_fdacleared2018-10-25

  Applicant: Zimmer Biomet

Incidents affecting ROSA (1)

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

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.

Who makes ROSA?

ROSA is made by Zimmer Biomet, based in Warsaw, Indiana, USA.

Where is ROSA deployed?

No verified deployments of ROSA 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 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.

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