{"id":"568e84d3-d723-4e72-be68-025e42d681a9","slug":"regulatory-action-2026-06-15-think-surgical","kind":"regulatory_action","headline":"THINK Surgical receives FDA 510(k) clearance for TMINI 1.1","summary":"THINK Surgical received second FDA 510(k) clearance for TMINI 1.1 Miniature Robotic System in less than 15 months.","occurredAt":"2026-06-15T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"fcbc42cb-7267-41d7-ab02-10d4838d2a93","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,"createdAt":"2026-07-03T14:21:15.014Z","updatedAt":"2026-07-03T14:21:15.014Z","model":null,"deployment":null,"company":{"id":"fcbc42cb-7267-41d7-ab02-10d4838d2a93","name":"THINK Surgical","slug":"think-surgical","description":"[THINK Surgical](https://thinksurgical.com) is a medical robotics company based in Fremont, California, developing the TMINI Miniature Robotic System for robotic-assisted total knee arthroplasty. The TMINI system is unique in supporting multiple implant manufacturers (Zimmer Biomet, Medacta, Stryker, Maxx Orthopedics, Waldemar Link, b-ONE Ortho) through its proprietary TPLAN software and ID-HUB implant data platform, enabling surgeon choice in robotic orthopedic surgery. The system received FDA 510(k) clearance in May 2023 and has been used in over 5,000 procedures as of May 2026.","status":null,"founded":2007,"hq":"Fremont, California, USA","fundingTotal":"5000000","type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/","title":"THINK Surgical Receives FDA 510(k) Clearance for TMINI 1.1","sourceName":"THINK Surgical"}],"keyFacts":[{"label":"Product","value":"TMINI Miniature Robotic System"},{"label":"FDA clearance","value":"510(k) May 2023"},{"label":"Procedures","value":"5000+ (May 2026)"},{"label":"Implant partners","value":"Zimmer Biomet, Medacta, Stryker, Maxx Orthopedics, Waldemar Link, b-ONE Ortho"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-03T14:20:55.194Z","updatedAt":"2026-07-03T14:26:55.697Z"},"derived":{"status":"active"},"sources":[{"id":"b6c7fb31-7940-4cef-a041-b8f52b7d9b26","incidentId":"568e84d3-d723-4e72-be68-025e42d681a9","url":"https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/","label":null,"publishedAt":null,"notes":null,"title":"THINK Surgical Receives FDA 510(k) Clearance for TMINI 1.1","sourceName":"THINK Surgical","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T14:21:15.171Z","updatedAt":"2026-07-03T14:21:15.171Z"}],"responses":[],"statusEvents":[{"id":"bb270ce7-3b2d-4149-87c9-f9fa09c55564","incidentId":"568e84d3-d723-4e72-be68-025e42d681a9","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T14:21:15.327Z","createdAt":"2026-07-03T14:21:15.328Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-think-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-think-surgical","headline":"THINK Surgical receives FDA 510(k) clearance for TMINI 1.1","description":"THINK Surgical received second FDA 510(k) clearance for TMINI 1.1 Miniature Robotic System in less than 15 months.","identifier":"568e84d3-d723-4e72-be68-025e42d681a9","datePublished":"2026-06-15T12:00:00.000Z","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":"unreviewed","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":1,"primary_source_types":[]}}}