ExplainersSurgical robotics
Surgical robotics
FDA clearance as gating event applied symmetrically across corporate-scale and emerging entrants. Autonomy bounded by clearance scope.
18 explainers
The surgical robotics cohort sits adjacent to the broader physical AI landscape but operates a distinct regulatory framework (FDA clearance as gating event), distinct customer base (hospital systems + surgical-services networks), and distinct verification discipline. The framework reads surgical manufacturers symmetrically across corporate-scale and emerging entrants: pre-clearance is pre-clearance regardless of company scale. J&J Ottava (De Novo submission January 2026; FDA records "not authorized to be marketed") and Vicarious Surgical V1 (SPAC-era hype, distressed pre-market) sit at the same research tier despite distinct corporate-scale and capital histories. Both lack the verified gating event.
The autonomy spectrum is bounded by FDA clearance scope. The cohort's spectrum runs from teleoperated baseline (da Vinci, Hugo, Versius, Senhance, Dexter; surgeon directly controls instruments through console) through analytics AI on shipped hardware (Intuitive's analytics features layered onto teleoperated baseline) through narrow autonomous functions (Moon Surgical Maestro Laparoscopy Co-Pilot as the cohort's genuine shipped assistive-AI exemplar, FDA 510(k) K240598 cleared June 2024; ScoPilot autonomous-registration with Predetermined Change Control Plan; Brain Navi NaoTrac for autonomous registration) to research demos on production hardware. Autonomous tissue manipulation in clinical use does not yet exist as a shipped product.
Five structural axes operate at editorial-anchor depth on the surgical cluster per the Wave 3 expansion + Monogram autonomy-boundary extension. FDA-clearance-posture axis (Wave 1 surgical FDA-clearance triangle): Intuitive da Vinci cleared multi-procedure with substantial installed-base + Medtronic Hugo IDE-pivotal pathway commercial in CE-Mark regions + J&J Ottava De Novo pre-market state. Clinical-domain axis (Wave 2): CMR Versius UK-headquartered modular soft-tissue surgical with international commercial deployment across EU + UK + Australia + India; US FDA state cap-flagged. Commercial-model variance axis (Wave 2): Moon Surgical Maestro ASSISTIVE (NOT replacement) laparoscopy co-pilot with smaller-footprint OR integration. Sub-cohort triangle structure axis (Wave 3 orthopedic): Stryker Mako large-footprint CT-based + Smith+Nephew CORI handheld imageless + Zimmer Biomet ROSA mid-size cross-domain; parallels biometric ring sub-cohort triangle pattern within surgical form_factor. Autonomy-boundary axis (Wave 3 extension): Monogram mBos autonomy-boundary case (semi-autonomous FDA-cleared March 17, 2025; KUKA arm executes bone cut; robot cuts NOT surgeon; pre-commercial; ZB acquired Oct 7, 2025 ~$168M EV + CVR). The four-way autonomy-boundary distinction (autonomous-execution Monogram + AI-augmented surgeon-controlled Mako/CORI/ROSA + replacement-robotics teleoperated da Vinci/Hugo/Ottava/Versius + assistive laparoscopy co-pilot Maestro) is the load-bearing architectural distinction within the surgical cluster.
The orthopedic sub-cohort triangle operates with AI-augmented-surgeon-controlled-not-autonomous framing consistently applied across all three anchors plus the broader cluster (da Vinci + Maestro): software plans/tracks/bounds, surgeon makes the cuts. The assistive-vs-autonomous distinction is editorial signal at the verification-posture layer; trade-press coverage framing orthopedic-robotic systems as "autonomous surgical robots" operates outside primary-source-anchored verification. Two critical Agent A corrections preserve cohort verification posture: ROSA Spine LEFT Zimmer Biomet in 2022 ZimVie spinoff (NOT a current ZB variant); ZB autonomy enters via SEPARATE Monogram acquisition NOT ROSA (kept distinct so AI-augmented-not-autonomous framing holds consistently). One critical Smith+Nephew CORI honesty distinction: hip is NAVIGATION-ONLY NOT robotic (common aggregator confusion blurs this; knee is robotic, hip is navigation-only). Per Agent A Stryker entity correction: HQ Portage MI (NOT Kalamazoo).
Installed-base scale dominates the cohort: Intuitive Surgical's 11,395 da Vinci systems + 1,041 Ion systems per SEC 10-Q dwarfs the combined installed base of all competitor platforms. Trade-press coverage that frames new entrants as "challenging Intuitive's dominance" should be read against the installed-base differential, not just clearance milestones. The architectural distinction between Versius modular (separate cart-mounted arms) and da Vinci monolithic (single patient-side cart) operates as the secondary cluster architectural axis within replacement-robotics; the assistive-vs-replacement distinction at Maestro operates at the broader commercial-model variance layer; the form-factor variance within the orthopedic sub-cohort triangle (large-footprint CT-based + handheld imageless + mid-size cross-domain) operates as the sub-cohort architecture axis. Stryker SEC framing is "one of four leading global competitors" with NO specific market-share % asserted; aggregator-quoted market-share figures cap-flagged consistently across cohort.
Consumer pricing covers the cohort's expanded coverage: Intuitive da Vinci (verified-at-scale anchor); Medtronic Hugo (large-prime IDE-pivotal); J&J Ottava (pre-market research). Agent B's parallel surgical Wave 2 /price expansion (cmr-versius + moon-maestro) ships in coordination; planned orthopedic sub-cohort /price triangle expansion (stryker-mako + smith-nephew-cori + zimmer-biomet-rosa) ships in subsequent Agent B Wave 3 /price coordination. Broader cohort coverage (Asensus Senhance, Distalmotion Dexter, Brain Navi NaoTrac, Brainlab Cirq, Stereotaxis Genesis, Monarch MK-V) lives on the registry's /surgical category at canonical institutional depth. The consumer category surface is deploy.report/surgical.
For the framework canonical reference + canonical worked examples demonstrating the discipline operationally, see how DEPLOY verifies. For the canonical category umbrella that includes surgical robotics alongside the other physical AI cohorts, see what is physical AI.
For methodology pillar canonical references applicable to the surgical cohort: the 4-way autonomy-boundary taxonomy (CANONICAL: autonomous-execution + AI-augmented operator-controlled + replacement-robotics teleoperated + assistive co-pilot all surface in surgical cohort as the canonical cross-cohort worked example); verified-vs-claimed at within-entity granularity (Mako multi-procedure within-entity clearance state worked example); the 9-tier source-quality rubric (FDA + SEC + per-claim source classification across surgical platform claims).
Adjacent clusters
- Humanoid robots: Surgical robotics and humanoids both sit under the physical AI canonical umbrella; humanoid-robots carries the broadest cohort context.
- Industrial robotics: Adjacent task-specific physical AI corner (industrial automation operates outside controlled operating-room environment; FDA-clearance discipline parallels OSHA + customer-procurement gating).
Featured
What is Intuitive Surgical and the da Vinci surgical robot?
Intuitive Surgical is the verified-at-scale anchor of the surgical robotics cohort. Per SEC 10-Q registry source-of-truth, installed base is 11,395 da Vinci systems + 1,041 Ion systems; the installed base dwarfs combined competitor installed base. da Vinci 5 was FDA-cleared March 2024 as the current product generation; Ion is a separate robotic-bronchoscopy product line. Architecture is teleoperated baseline with shipped analytics AI; autonomous suturing work on da Vinci hardware is research demos, not shipped product. Maturity: production. Per DEPLOY's framework, da Vinci is the gold standard verified deployment all other surgical entrants are measured against.
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What is Stryker Mako?
Stryker Mako is a large-footprint CT-based robotic-arm-assisted orthopedic surgical system from Stryker (NYSE: SYK; HQ Portage, MI per Agent A correction, NOT Kalamazoo). Mako was acquired in 2013 via Stryker's $1.65B acquisition of MAKO Surgical. Per Agent A orthopedic ingest: FDA-cleared multi-procedure (partial + total + cementless knee + hip + hip-revision + spine via K241517 + shoulder via K242373); CT-based pre-op planning + robotic-arm-assisted intra-op execution. AI-augmented surgeon-controlled assistance (NOT autonomous; software plans/tracks/bounds, surgeon makes the cuts); same assistive class as Intuitive da Vinci, framed honestly + consistently across the cohort. Editorial throughline: large-footprint orthopedic market-leader archetype within the surgical cluster's orthopedic sub-cohort; multi-procedure platform spanning knee + hip + spine + shoulder; SEC-disclosed parent-company verification depth.
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What is Monogram mBos?
Monogram mBos (Monogram Bone Orthopedic Surgical platform) is an autonomy-boundary case within the surgical cluster from Monogram Orthopaedics. Per Agent A precision corrections: FDA-cleared March 17, 2025 for semi-autonomous version (KUKA-based robotic arm executes bone cut under AI control within surgeon-approved CT plan and supervision; the ROBOT cuts, NOT the surgeon. Structurally distinct from AI-augmented surgeon-controlled orthopedic systems like Stryker Mako + Smith+Nephew CORI + Zimmer Biomet ROSA where the SURGEON makes the cuts). Doug Unis CMO/founder (NOT CEO; pre-acquisition CEO was Benjamin Sexson). Zimmer Biomet acquired Monogram closed October 7, 2025 (~$168M EV + CVR). Fully-autonomous version NOT cleared (in development ~2027/2028; first live-patient case July 2025 India CDSCO trial, NOT US FDA; single index case with no peer-reviewed outcomes). Pre-commercial (not sold any units yet) maturity research. CRITICAL CAP-FLAG: 'semi-autonomous' is ZB/trade-sourced framing, NOT FDA-letter-verbatim (Monogram's own PR uses 'robotic-assisted TKA'). Cohort positioning: autonomy-boundary case extending the surgical cluster's architectural axes; demonstrates within-form_factor architectural-axis extension via robot-cuts-not-surgeon distinction.
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What is CMR Versius?
CMR Versius is a modular soft-tissue surgical robotic system from CMR Surgical, a UK-based company founded in 2014. Per DEPLOY's surgical cluster framework: international commercial soft-tissue surgical archetype with established commercial deployment volume across EU + UK + Australia + India; US FDA clearance state operates at cap-flag posture pending primary-source confirmation of submission status. Editorial distinction: modular architecture (separate cart-mounted instrument arms) structurally distinct from Intuitive da Vinci monolithic design (single patient-side cart). Three editorial axes within one entity: international commercial soft-tissue surgical archetype + modular-architecture distinction from Intuitive's monolithic design + non-US market state. Cohort positioning: international commercial soft-tissue surgical archetype within the surgical cluster, extending the cluster's structural axes from FDA-clearance-posture (Wave 1) into clinical-domain + commercial-model variance.
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Sub-cohort · 3 explainers
Intuitive Surgical da Vinci
Intuitive ships da Vinci at multi-year commercial-deployed scale: 11,395 da Vinci systems plus 1,041 Ion systems per SEC 10-Q. The framework distinguishes safety events at year and product-family granularity across SureForm and EndoWrist.
What is Intuitive Surgical and the da Vinci surgical robot?
Intuitive Surgical is the verified-at-scale anchor of the surgical robotics cohort. Per SEC 10-Q registry source-of-truth, installed base is 11,395 da Vinci systems + 1,041 Ion systems; the installed base dwarfs combined competitor installed base. da Vinci 5 was FDA-cleared March 2024 as the current product generation; Ion is a separate robotic-bronchoscopy product line. Architecture is teleoperated baseline with shipped analytics AI; autonomous suturing work on da Vinci hardware is research demos, not shipped product. Maturity: production. Per DEPLOY's framework, da Vinci is the gold standard verified deployment all other surgical entrants are measured against.
How does DEPLOY track the 2026 da Vinci SureForm gray-reload Class I recall?
DEPLOY tracks the [2026 da Vinci SureForm gray-reload Class I recall](https://registry.deploy.report/incidents/davinci-sureform-gray-reload-recall-death-2026) at primary-source-anchored FDA-recall-database verification depth as the surgical cohort's most severe verified incident. The substrate: 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) produced incomplete staple lines on blood vessels despite a 'completed' fire indication; customer letter / quarantine March 11, 2026; FDA classified Class I (reported May 2026); 1 death + 4 serious injuries (bleeding). Blue/white reloads UNAFFECTED at canonical within-product-family verification scope distinction. The framework reads the incident at four substrate layers simultaneously: incident-recall actuarial depth per Phase 3 Dim 1 (severity=critical at primary-source-anchored verification; cohort's most severe); within-entity verification scope at sub-product-line granularity (gray vs blue/white reload distinction is the within-da-Vinci feature-level verification posture distinct); regulatory clearance per jurisdiction at Dim 4 (FDA Class I primary-government-record sub-tier verification); year-discipline framework distinguishing the 2026 gray-reload recall from the 2022 SureForm fragment recall (Z-0340-2023; Class II; October 7, 2022) at year-class-failure-mode granularity. Cap-flag honest-absence at exact recall Z-number + unit count (not captured from primary FDA pages). Root cause stated 'still under investigation' at primary-source-anchored verification depth.
How does DEPLOY distinguish da Vinci safety events at year-class-failure-mode-product-variant granularity?
DEPLOY tracks within-da-Vinci-product-family safety events at year-class-failure-mode-product-variant granularity per Agent A's surgical incidents substrate. The three canonical worked examples span distinct product lines + distinct years + distinct classes + distinct failure modes simultaneously: [2013 EndoWrist Hot Shears Class I recall](https://registry.deploy.report/incidents/davinci-hot-shears-burn-recall-2013) (May 8, 2013 Urgent Medical Device Notification; '-09'/'-10' versions; insulation micro-cracks near distal shaft after cleaning/sterilization create monopolar energy arc path; burn tissue outside surgical field; 134 tip-cover complaints + 82 MDRs Jan 2010-Dec 2011; remediated via instrument version supersession; load-bearing historical da Vinci safety event); [2022 SureForm fragment Class II recall](https://registry.deploy.report/incidents/davinci-sureform-stapler-fragment-recall-2022) (Z-0340-2023; October 7, 2022; da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads; intraoperative device-fragment generation; potential staple deployment failure); [2026 SureForm gray-reload Class I recall](https://registry.deploy.report/incidents/davinci-sureform-gray-reload-recall-death-2026) (March 11, 2026 customer letter + Class I reported May 2026; 8mm SureForm 30 Gray reloads; incomplete staple lines on blood vessels; 1 death + 4 serious injuries; cohort's most severe per [the 2026 gray-reload framework-in-action narrative](/explainers/how-deploy-tracks-the-2026-davinci-sureform-gray-reload-class-i-recall)). Plus adjacent [2013 FDA Warning Letter regulatory_action](https://registry.deploy.report/incidents/intuitive-fda-warning-letter-2013) (July 19, 2013; distinct from May 2013 device recall; reporting-compliance regulatory action; serious severity; cap-flag honest-absence at primary FDA letter direct retrieval). Aggregator coverage frequently collapses 'da Vinci recalls' across years; the framework distinguishes them structurally at four substrate axes simultaneously (year + class + failure mode + product variant) per [verified-vs-claimed at within-entity granularity methodology pillar](/explainers/verified-vs-claimed-within-entity).
Sub-cohort · 2 explainers
Stryker Mako
Stryker ships Mako at the orthopedic large-footprint CT-based anchor. Stryker is headquartered in Portage, Michigan; SEC 10-K verifies, not Kalamazoo as aggregator coverage frequently asserts.
What is Stryker Mako?
Stryker Mako is a large-footprint CT-based robotic-arm-assisted orthopedic surgical system from Stryker (NYSE: SYK; HQ Portage, MI per Agent A correction, NOT Kalamazoo). Mako was acquired in 2013 via Stryker's $1.65B acquisition of MAKO Surgical. Per Agent A orthopedic ingest: FDA-cleared multi-procedure (partial + total + cementless knee + hip + hip-revision + spine via K241517 + shoulder via K242373); CT-based pre-op planning + robotic-arm-assisted intra-op execution. AI-augmented surgeon-controlled assistance (NOT autonomous; software plans/tracks/bounds, surgeon makes the cuts); same assistive class as Intuitive da Vinci, framed honestly + consistently across the cohort. Editorial throughline: large-footprint orthopedic market-leader archetype within the surgical cluster's orthopedic sub-cohort; multi-procedure platform spanning knee + hip + spine + shoulder; SEC-disclosed parent-company verification depth.
Why does DEPLOY surface Stryker as headquartered in Portage, MI, not Kalamazoo?
Common framing across press coverage + aggregator listings + secondary references identifies [Stryker Corporation](https://registry.deploy.report/companies/stryker) as headquartered in Kalamazoo, Michigan. Per Agent A primary-source verification against SEC 10-K filings, Stryker is headquartered in **Portage, Michigan**, not Kalamazoo. Small fact. Foundational at the framework-discipline layer. The Stryker headquarters correction is the canonical worked example of small-fact discipline cuts uniformly: DEPLOY reads single-city location identification at the same primary-source verification depth as $5.6B-vs-$11B valuation corrections + Doug-Unis-CMO-vs-CEO leadership corrections + corporate-state-transition multi-fact precision. The framework operates at per-claim depth; per-claim depth doesn't scale with company size or fact magnitude. This piece documents the catch as framework-in-action worked example demonstrating small-fact discipline + primary-source verification at single-city location identification depth + uniform application of the framework across granularity.
Sub-cohort · 2 explainers
Zimmer Biomet ROSA
Zimmer Biomet ships ROSA across cross-domain orthopedic and neuro applications. ROSA Spine left ZB in the 2022 ZimVie spinoff. ZB's autonomy entry is the separate Monogram acquisition; ROSA stays AI-augmented-surgeon-controlled.
What is Zimmer Biomet ROSA?
Zimmer Biomet ROSA (Robotic Surgical Assistant) is a mid-size cross-domain multi-procedure surgical robotic platform from Zimmer Biomet Holdings (NYSE: ZBH). Per Agent A orthopedic ingest: cleared for knee + hip (direct-anterior) + brain (SEEG/DBS) + shoulder; ROSA brain technology came via Medtech SA acquisition 2016 + subsequent extension to orthopedics. CRITICAL CORRECTIONS per Agent A: (1) ROSA Spine LEFT Zimmer Biomet in the 2022 ZimVie spinoff (NOT a current ZB variant); (2) ZB autonomy enters via SEPARATE Monogram acquisition, NOT ROSA (kept distinct so AI-augmented-not-autonomous framing holds across the orthopedic sub-cohort consistently). AI-augmented surgeon-controlled assistance (same assistive class as Mako + CORI + da Vinci + Maestro). Cohort positioning: mid-size cross-domain multi-procedure platform spanning orthopedics + neurosurgery within the Wave 3 orthopedic sub-cohort triangle.
How does DEPLOY track the 2021 ROSA ONE Brain wrong-trajectory Class I recall?
DEPLOY tracks the [2021 Zimmer Biomet ROSA ONE Brain 3.1 wrong-trajectory Class I recall](https://registry.deploy.report/incidents/rosa-one-brain-trajectory-recall-2021) at primary-source-anchored FDA-recall-database verification depth as a software_defect Class I recall within the ZB cluster's neurosurgical-platform product line. The substrate: urgent correction issued September 22, 2021 + FDA Class I designation November 2021; on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke / serious-injury risk); 119 US devices at exact verification depth; 3 complaints (one inaccurate electrode placement); no patient injuries reported; software corrective update rolled out 2022; remediated. Root cause: software_defect (post-reboot calibration sequence could misinterpret coordinates and drive an instrument to an incorrect trajectory). The framework reads the incident at four substrate layers simultaneously: incident-recall actuarial depth per Phase 3 Dim 1 (severity=critical at primary-source-anchored verification; software_defect root cause; remediated status); within-ZB-cluster verification scope at sub-product-line granularity (ROSA ONE Brain neurosurgical platform vs ROSA Spine vs Mako orthopedic vs Monogram orthopedic per ZB cluster densest in corpus); cross-property acquisition history bidirectional compounding (ZB cluster ROSA ONE Brain retained per ZimVie spinoff 2022 vs ROSA Spine LEFT ZB in 2022 ZimVie spinoff per Agent A correction; ZB acquired Monogram closed October 7, 2025 ~$168M EV + CVR canonical contingent valuation_basis worked example per acquisition history Project B methodology pillar); software_defect root cause class with remediation discipline at primary-source-anchored verification depth. Cap-flag honest-absence at exact recall Z-number not captured from primary FDA pages; reputable-press source-quality tier per FierceBiotech + Becker's coverage of FDA recall record.
Sub-cohort · 1 explainer
Medtronic Hugo
Medtronic ships Hugo under the IDE-pivotal pathway. Commercial in CE-Mark regions. The K250725 filing is fda_510k, not de_novo, per primary-source correction.
Sub-cohort · 1 explainer
Asensus Senhance
Asensus shipped Senhance pre-acquisition. Karl Storz closed the Asensus acquisition August 22, 2024. The 2023 uncontrolled-arm Class I recall sits at the pre-acquisition corporate state.
Sub-cohort · 2 explainers
Monogram
Monogram shipped mBos with semi-autonomous FDA clearance March 17, 2025. The KUKA arm executes the bone cut; robot cuts, not surgeon. Doug Unis is CMO and founder, not CEO. ZB closed the Monogram acquisition October 7, 2025 at approximately $168M EV plus CVR.
What is Monogram mBos?
Monogram mBos (Monogram Bone Orthopedic Surgical platform) is an autonomy-boundary case within the surgical cluster from Monogram Orthopaedics. Per Agent A precision corrections: FDA-cleared March 17, 2025 for semi-autonomous version (KUKA-based robotic arm executes bone cut under AI control within surgeon-approved CT plan and supervision; the ROBOT cuts, NOT the surgeon. Structurally distinct from AI-augmented surgeon-controlled orthopedic systems like Stryker Mako + Smith+Nephew CORI + Zimmer Biomet ROSA where the SURGEON makes the cuts). Doug Unis CMO/founder (NOT CEO; pre-acquisition CEO was Benjamin Sexson). Zimmer Biomet acquired Monogram closed October 7, 2025 (~$168M EV + CVR). Fully-autonomous version NOT cleared (in development ~2027/2028; first live-patient case July 2025 India CDSCO trial, NOT US FDA; single index case with no peer-reviewed outcomes). Pre-commercial (not sold any units yet) maturity research. CRITICAL CAP-FLAG: 'semi-autonomous' is ZB/trade-sourced framing, NOT FDA-letter-verbatim (Monogram's own PR uses 'robotic-assisted TKA'). Cohort positioning: autonomy-boundary case extending the surgical cluster's architectural axes; demonstrates within-form_factor architectural-axis extension via robot-cuts-not-surgeon distinction.
Why DEPLOY surfaces Doug Unis as Monogram's CMO/founder, not CEO
Trade-press coverage of [Monogram Orthopaedics](https://registry.deploy.report/companies/monogram) (acquired by Zimmer Biomet closing October 7, 2025 for approximately $168M enterprise value plus contingent value rights) frequently identifies Doug Unis as CEO. Per Agent A primary-source verification, Unis is Monogram's CMO and founder. Pre-acquisition CEO was Benjamin Sexson. Small fact at one level. Foundational at another: the framework discipline cuts uniformly at every granularity of entity identification. Trade-press coverage that frames Doug Unis as CEO operates outside primary-source-anchored verification of the founder + CMO + pre-acquisition-CEO role distinctions. This piece documents the catch as a framework-in-action worked example: small-fact discipline + entity-identification precision + post-acquisition leadership scope cap-flagged transparently. Per [DEPLOY's surgical cluster framework](/explainers/surgical-robotics), Monogram operates the autonomous-execution archetype within the 4-way autonomy-boundary taxonomy (Monogram mBos KUKA robotic arm executes bone cut under AI control; the robot cuts, NOT the surgeon); the leadership correction operates at the same primary-source verification discipline as the autonomy-classification correction (semi-autonomous is ZB/trade-sourced framing, NOT FDA-letter-verbatim). Per [DEPLOY's acquisition history Project B methodology pillar](/explainers/how-deploy-tracks-acquisition-history-state), the ZB × Monogram acquisition operates as the CANONICAL worked example for the contingent valuation_basis state (full_acquisition structure + contingent valuation_basis composition; ~$168M EV + CVR earnout). Per Arc A people graph substrate, the Doug Unis PersonCompany edge cross-references the acquisition record bidirectionally at cross-property authority depth.
Sub-cohort · 5 explainers
Emerging
Pre-commercial or early-commercial surgical entrants. J&J Ottava (De Novo submission January 2026; FDA records not authorized to market), CMR Versius (UK-headquartered modular soft-tissue; US FDA state cap-flagged), Moon Surgical Maestro (assistive laparoscopy co-pilot; FDA 510(k) K240598 cleared June 2024), and Smith+Nephew CORI (handheld imageless; hip is navigation-only, knee is robotic).
What is Johnson & Johnson Ottava?
Johnson & Johnson Ottava is a surgical robotics platform under development by J&J. Per Agent A foundational ingest, Ottava submitted a De Novo to FDA in January 2026; FDA records list Ottava as 'not authorized to be marketed.' Per DEPLOY's FDA-clearance-as-gating-event framework, Ottava sits at research tier despite J&J's corporate scale. Maturity: research. The pre-market positioning despite J&J's massive medical-device portfolio is the editorial throughline: DEPLOY's framework treats Ottava at the same research tier as Vicarious Surgical V1's distressed pre-market state because both lack the verified gating event. Surfacing this transparently demonstrates the framework discipline applied to household-name corporate scale.
What is CMR Versius?
CMR Versius is a modular soft-tissue surgical robotic system from CMR Surgical, a UK-based company founded in 2014. Per DEPLOY's surgical cluster framework: international commercial soft-tissue surgical archetype with established commercial deployment volume across EU + UK + Australia + India; US FDA clearance state operates at cap-flag posture pending primary-source confirmation of submission status. Editorial distinction: modular architecture (separate cart-mounted instrument arms) structurally distinct from Intuitive da Vinci monolithic design (single patient-side cart). Three editorial axes within one entity: international commercial soft-tissue surgical archetype + modular-architecture distinction from Intuitive's monolithic design + non-US market state. Cohort positioning: international commercial soft-tissue surgical archetype within the surgical cluster, extending the cluster's structural axes from FDA-clearance-posture (Wave 1) into clinical-domain + commercial-model variance.
What is Moon Surgical Maestro?
Moon Surgical Maestro is the Maestro Laparoscopy Co-Pilot, an FDA-cleared ASSISTIVE (NOT replacement) robotic system for laparoscopic procedures from Moon Surgical, a French-US dual-base company founded 2020. Per DEPLOY's surgical cluster framework: FDA 510(k) K240598 cleared June 2024 (primary-source FDA database verification). EDITORIAL DISTINCTION: assistive-laparoscopy positioning. Maestro augments surgeons within existing laparoscopic procedures rather than replacing them as full surgical platforms (Intuitive da Vinci, Medtronic Hugo, CMR Versius, J&J Ottava). Smaller-footprint OR integration + commercial-niche positioning. Per DEPLOY's surgical cluster framework, Maestro is the cohort's genuine shipped assistive-AI exemplar within the broader replacement-robotics cluster. Cohort positioning: assistive-laparoscopy commercial-niche archetype within the surgical cluster, extending the cluster's structural axes from FDA-clearance-posture (Wave 1) into clinical-domain + commercial-model variance (Wave 2).
What is Smith+Nephew CORI?
Smith+Nephew CORI is a handheld imageless orthopedic surgical robotic system from Smith+Nephew (LSE: SN / NYSE: SNN). Per Agent A orthopedic ingest: FDA-cleared for total + partial + revision knee. CRITICAL HONESTY DISTINCTION: hip is NAVIGATION-ONLY, NOT robotic; common aggregator confusion blurs this; surfaced explicitly with cap-flag (knee is robotic; hip is navigation-only). Acquired Blue Belt Technologies 2015 → Navio → CORI 2020 evolution lineage. AI-augmented surgeon-controlled assistance (NOT autonomous; same assistive class as Mako + da Vinci + ROSA). Editorial throughline: handheld imageless commercial-niche archetype distinct from Stryker Mako's large-footprint CT-based architecture; knee-only robotic scope with navigation-only hip; smaller-footprint OR integration. Cohort positioning: handheld imageless orthopedic archetype within the surgical cluster's Wave 3 orthopedic sub-cohort triangle.
How did DEPLOY correct the Moon Maestro FDA clearance date?
DEPLOY's Moon Maestro entity anchor originally framed FDA 510(k) clearance as 'December 2023 (specific K-number at cap-flag pending primary-source confirmation).' The framing was honest cap-flag discipline at the time: month-precision claim with K-number explicitly held at cap-flag pending primary-source-anchored verification. Primary-source FDA database research per Agent A surfaces K240598 cleared June 2024. Both the K-number resolves (K240598) AND the date was off by six months (June 2024, not December 2023). The reconciliation operates as a worked example of DEPLOY's verified-vs-claimed framework applied recursively to DEPLOY's own corpus: cap-flag-honestly until primary source confirms; update + surface the change transparently via inline editorial-transparency footer + framework-in-action correction narrative when primary source surfaces. The catch is the discipline operating on itself. Per [DEPLOY's framework discipline](/explainers/how-deploy-verifies), recursive application of cap-flag + primary-source-anchored verification on DEPLOY's own published corpus + transparent surfacing of correction in entity-anchor footer + canonical worked-example narrative at correction-tier depth compounds editorial credibility at the operational-practice layer.
All explainers in surgical robotics
How does DEPLOY track supply-chain component failure modes chained to recall incidents?
DEPLOY tracks Phase 3 Dim 3 supply-chain component failure mode substrate at primary-source-anchored verification depth per Agent A's surgical-cluster baseline backfill: 5 safety-critical components (da Vinci SureForm Stapler + da Vinci Instrument Arm + Stryker Mako Robotic Arm (RIO) + ROSA ONE Brain Navigation System + Senhance Instrument Arm) chained to 6 failure modes chained to 6 real recall incidents via component_failure_incidents junction table at unified verification posture. Severity distribution at canonical primary-source verification depth: 2 serious + 2 critical + 1 catastrophic + 1 moderate. Source-inheritance discipline CANONICAL: each component_failure_mode inherits the linked incident's primary source as its evidence (the recall that attests the failure attests the failure mode) satisfying Agent B's f6e9cd6 validator cited-evidence check with ZERO new-URL fabrication. Failure-mode-class distribution at structurally-distinct cross-cohort root cause typed-record depth: software_fault 3 (da Vinci Instrument Arm 2025 + Stryker Mako 2024 + ROSA ONE Brain 2021 per canonical [software_defect-as-cross-cohort-root-cause-class structural class](/explainers/how-deploy-tracks-the-2021-rosa-one-brain-wrong-trajectory-class-i-recall)) + mechanical_wear 1 (SureForm fragment 2022) + actuator_failure 1 (Senhance uncontrolled-arm 2023) + other 1 (SureForm gray-reload 2026 with root cause stated 'still under investigation'). Cap-flag-as-trust-signal at honest-absence: failure modes authored ONLY where a real recall incident chain exists; speculative failure-mode authoring rejected per canonical editorial-credibility discipline. AV ADAS safety-critical components documented as Wave 2 (broader cohort scope; less cleanly incident-linked per editorial scoping discipline).
What is a surgical robot?
A surgical robot is a computer-assisted operative platform that places robotic arms, instruments, and visualization systems between the surgeon and the patient. The 2026 commercial cohort includes Intuitive Surgical (da Vinci + Ion; 11,395 + 1,041 systems installed per SEC 10-Q), Medtronic Hugo, CMR Surgical Versius, Asensus/Karl Storz Senhance, Stereotaxis Genesis, Distalmotion Dexter, Moon Surgical Maestro (ScoPilot is the cohort's genuine shipped surgical AI standout, FDA-cleared with a Predetermined Change Control Plan), and Brain Navi NaoTrac (autonomous registration, not tissue manipulation). J&J Ottava (De Novo submission January 2026) and Vicarious Surgical V1 remain pre-market research per DEPLOY's FDA-clearance-as-gating-event framework. The autonomy spectrum runs from teleoperated baseline through analytics AI to narrow autonomous registration; tissue-manipulation autonomy remains research demos on production hardware, not shipped product.