{"id":"dfd7a602-92b3-4537-8cae-7735bb6e3785","slug":"regulatory-action-2026-06-23-lem-surgical","kind":"regulatory_action","headline":"LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system","summary":"FDA's K260369 record documents a June 20, 2026 510(k) decision for LEM Surgical's Dynamis Robotic Surgical System, including expanded navigation capabilities and vertebra tracking ([FDA K260369](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf)).","occurredAt":"2026-06-23T12:00:00.000Z","reviewStatus":"reviewed","modelId":"a5d597fd-ae0b-4e49-9e3a-6148d2bc7bd9","deploymentId":"96ee4a84-0952-4ae4-b02a-8e5c00ba92d4","companyId":"2b651b74-6e01-4d10-8fc3-7bb18690e89c","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-03T17:32:05.612Z","updatedAt":"2026-09-29T20:00:50.815Z","model":{"id":"a5d597fd-ae0b-4e49-9e3a-6148d2bc7bd9","companyId":"2b651b74-6e01-4d10-8fc3-7bb18690e89c","modelName":"Dynamis Robotic Surgical System","slug":"dynamis","description":"Bern, Switzerland-based medical robotics company founded in 2021 by Prof. Dr. Stefan Weber, Prof. Dr. Andreas Raabe, Marco Matulic, Simon Michel, and Yossi Bar. LEM Surgical develops the Dynamis robotic surgical system, a next-generation integrated navigation-based platform for hard tissue and spine surgery. Showcased in NVIDIA's CES 2026 keynote. Raised CHF 22M in Series B funding.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/","title":"LEM Surgical wins new FDA clearance for humanoid surgical robot","sourceName":"MassDevice"},{"url":"https://lemsurgical.com/product-robotic-surgery-system/","title":"Robotic Surgery with the Dynamis Robotic Surgical System","sourceName":"LEM Surgical"},{"url":"https://lemsurgical.com/dynamis-robotic-surgical-system-receives-fda-clearance/","title":"Dynamis Robotic Surgical System Receives FDA Clearance","sourceName":"LEM Surgical"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"FDA 510(k)","value":"2 clearances (initial April 2025, second June 2026)"},{"label":"Product","value":"Dynamis Robotic Surgical System (spine/hard tissue surgery)"},{"label":"Navigation-based surgery","value":"LEM Surgical describes Dynamis as a multi-arm, navigation-based robotic platform for hard-tissue and spine surgery ([Dynamis Robotic Surgical System](https://lemsurgical.com/product-robotic-surgery-system/)).","sourceUrl":"https://lemsurgical.com/product-robotic-surgery-system/"},{"label":"Spine surgery scope","value":"LEM Surgical says Dynamis is designed to support cervical, thoracic, lumbar, and sacral spine procedures ([Dynamis Robotic Surgical System](https://lemsurgical.com/product-robotic-surgery-system/)).","sourceUrl":"https://lemsurgical.com/product-robotic-surgery-system/"},{"label":"FDA clearance","value":"LEM Surgical announced FDA clearance for the Dynamis Robotic Surgical System ([Dynamis FDA clearance](https://lemsurgical.com/dynamis-robotic-surgical-system-receives-fda-clearance/)).","sourceUrl":"https://lemsurgical.com/dynamis-robotic-surgical-system-receives-fda-clearance/"}],"createdAt":"2026-07-02T21:26:23.833Z","updatedAt":"2026-09-29T21:10:27.822Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":{"id":"96ee4a84-0952-4ae4-b02a-8e5c00ba92d4","modelId":"a5d597fd-ae0b-4e49-9e3a-6148d2bc7bd9","versionId":null,"locationId":"e0e2e87e-2f8b-4bdb-a362-27f23b2d471a","operatorId":"2b651b74-6e01-4d10-8fc3-7bb18690e89c","ownerId":null,"slug":"dynamis-switzerland-europe","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["surgical_assistance","microsurgery","precision_manipulation"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"city_centroid","deploymentScale":"small_2_10","siteEnvironment":"indoor","operatorType":"customer_deployed","sourceQualityTier":8,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[],"notes":"Commercial product — available for purchase in this market.","keyFacts":[],"reviewNote":"Bulk deepened — form-factor-based metadata assignment","exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-20T04:09:13.504Z","updatedAt":"2026-08-20T16:28:01.505Z"},"company":{"id":"2b651b74-6e01-4d10-8fc3-7bb18690e89c","name":"LEM Surgical","slug":"lem-surgical","description":"Bern, Switzerland-based medical robotics company founded in 2021 by Prof. Dr. Stefan Weber, Prof. Dr. Andreas Raabe, Marco Matulic, Simon Michel, and Yossi Bar. LEM Surgical develops the Dynamis robotic surgical system, a next-generation integrated navigation-based platform for hard tissue and spine surgery. Showcased in [Nvidia](/companies/nvidia)'s CES 2026 keynote. Raised CHF 22M in Series B funding.","status":"private","founded":2021,"hq":"Bern, Switzerland","hqLat":46.9484742,"hqLng":7.4521749,"hqGeocodedAt":"2026-08-05T14:36:41.452Z","hqAddress":null,"hqPrecision":null,"website":"lemsurgical.com","fundingTotal":"49000000","type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":75,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/","title":"LEM Surgical wins new FDA clearance for humanoid surgical robot","sourceName":"MassDevice"},{"url":"https://lemsurgical.com/product-robotic-surgery-system/","title":"Robotic Surgery with the Dynamis Robotic Surgical System","sourceName":"LEM Surgical"},{"url":"https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf","date":"2026-06-16","title":"K260369 Dynamis Robotic Surgical System","sourceName":"U.S. Food and Drug Administration"}],"keyFacts":[{"label":"FDA 510(k)","value":"2 clearances (initial April 2025, second June 2026)"},{"label":"CEO","value":"Yossi Bar"},{"label":"Co-founders","value":"Stefan Weber, Andreas Raabe, Marco Matulic, Simon Michel, Yossi Bar"},{"label":"Series B","value":"CHF 22M"},{"label":"Product","value":"Dynamis Robotic Surgical System (spine/hard tissue surgery)"},{"label":"Dynamis three-arm architecture","value":"LEM Surgical describes Dynamis as a compact robotic surgical system with three arms, with two arms for guidance and a third arm for tracking in spinal procedures ([Dynamis Robotic Surgical System](https://lemsurgical.com/product-robotic-surgery-system/)).","sourceUrl":"https://lemsurgical.com/product-robotic-surgery-system/"},{"label":"June 2026 FDA filing","value":"The FDA 510(k) document identifies the Dynamis Robotic Surgical System as a stereotaxic instrument submission under product code OLO, supporting LEM Surgical's stated spinal-surgery platform clearance ([Dynamis FDA 510(k)](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf)).","sourceUrl":"https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-07-02T21:26:23.674Z","updatedAt":"2026-09-29T22:12:23.834Z"},"derived":{"status":"active"},"sources":[{"id":"66062841-457d-4ef8-88b0-849b7e418521","incidentId":"dfd7a602-92b3-4537-8cae-7735bb6e3785","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf","label":null,"publishedAt":"2026-06-20T00:00:00.000Z","notes":null,"title":"K260369 Dynamis Robotic Surgical System decision letter","sourceName":"U.S. Food and Drug Administration","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-09-29T20:00:50.440Z","updatedAt":"2026-09-29T20:00:50.440Z"},{"id":"1d6302d8-898e-439e-9171-8956dea3b8ea","incidentId":"dfd7a602-92b3-4537-8cae-7735bb6e3785","url":"https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/","label":null,"publishedAt":null,"notes":null,"title":"LEM Surgical Announces second FDA 510(k) Clearance","sourceName":"SPINEMarketGroup","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T17:32:05.766Z","updatedAt":"2026-07-03T17:32:05.766Z"}],"responses":[],"statusEvents":[{"id":"4a18ef0f-3856-45cb-9f51-013e8199b9a1","incidentId":"dfd7a602-92b3-4537-8cae-7735bb6e3785","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T17:32:05.923Z","createdAt":"2026-07-03T17:32:05.924Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-06-23-lem-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2026-06-23-lem-surgical","headline":"LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system","description":"FDA's K260369 record documents a June 20, 2026 510(k) decision for LEM Surgical's Dynamis Robotic Surgical System, including expanded navigation capabilities and vertebra tracking ([FDA K260369](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260369.pdf)).","identifier":"dfd7a602-92b3-4537-8cae-7735bb6e3785","datePublished":"2026-06-23T12:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":2,"primary_source_types":["primary-fda-database"]}}}