{"entity":{"id":"establishment-labs","kind":"company","name":"Establishment Labs (Motiva)","aka":["Establishment Labs","Motiva","Motiva USA"],"tldr":"Establishment Labs makes Motiva breast implants and tissue expanders, approved in the United States in 2024.","summary":"Establishment Labs S.A. is registered with the FDA at Coyol, Alajuela, Costa Rica. Motiva USA, LLC holds PMA P230005 for Motiva SmoothSilk silicone gel-filled breast implants (approved 26 September 2024) and 510(k) K211676 for the Motiva Flora SmoothSilk tissue expander (13 October 2023).","asOf":"2026-11-04","links":[{"label":"FDA PMA P230005: Motiva SmoothSilk breast implants","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005"},{"label":"FDA 510(k) K211676: Motiva Flora tissue expander","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211676"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":[],"sections":["surgery","devices"],"technologies":["breast-implants","breast-tissue-expanders"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"hq":"Coyol, Alajuela","country":"CR","companyType":"devices","investors":[],"funding":[]},"route":"/companies/establishment-labs/","neighbours":{"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"breast-implants","kind":"technology","name":"Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)","route":"/technologies/breast-implants/"},{"id":"breast-tissue-expanders","kind":"technology","name":"Breast tissue expanders (saline and carbon dioxide)","route":"/technologies/breast-tissue-expanders/"}]}}