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.

ROSA is listed at $1,000,000 to $1,500,000 on the DEPLOY registry. This is an analyst estimate, not an official price.

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.

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.

2 verified deployments of ROSA are on the DEPLOY registry, including at France, United States.

ROSA is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.

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.

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.

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.

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, ROSA ranks in roughly the top 92% of surgical models tracked by the registry.

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.

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.

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.