# Establishment Labs (Motiva)

Source: https://onco.cc/companies/establishment-labs/  
OnCo record `establishment-labs` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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).

## Fields

- Kind: Company
- Last checked: 2026-11-04
- Also known as: Establishment Labs; Motiva; Motiva USA
- Tags: devices-gaps-2026-11
- HQ: Coyol, Alajuela
- Type: devices

## Sources

- FDA PMA P230005: Motiva SmoothSilk breast implants: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005
- FDA 510(k) K211676: Motiva Flora tissue expander: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211676

## Connected records

- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)](https://onco.cc/technologies/breast-implants/), [Breast tissue expanders (saline and carbon dioxide)](https://onco.cc/technologies/breast-tissue-expanders/)

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