Skip to content

Dunamis Fixation Button System

by Dunamis, LLC 510(k)

Active United States

510(k) K191319

Overview

The Dunamis Fixation Button System is a mechanical orthopedic implant designed for bone-to-bone or soft tissue-to-bone fixation. It includes titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports to secure bone or soft tissue to bone.

The system is supplied as a single-use device and is intended for use in orthopedic procedures. It is cleared under FDA 510(k) traditional pathway with product code MBI. Proper storage and handling are required to maintain sterility and functionality.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191319 Date29 Aug 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Dunamis, LLC

Questions

  • What is the Dunamis Fixation Button System used for?

    It is a mechanical orthopedic implant designed to secure bone or soft tissue to bone during surgical procedures.

  • Is the Dunamis Fixation Button System reusable?

    No, the system is supplied as a single-use device and should not be reused to maintain sterility and functionality.

  • What materials are used in the Dunamis Fixation Button System?

    The system includes titanium fixation buttons, non-absorbable suture loops, and optional passing sutures and button supports.

  • How is the device supplied?

    The system is supplied as a single-use device intended for use in orthopedic procedures.

  • What is the regulatory status of the Dunamis Fixation Button System?

    The device is cleared under the FDA 510(k) traditional pathway with product code MBI.