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RIGIDLOOP Titanium Button, RIGIDLOOP Cortical Fixation System XL Implant

by Medos International SARL

510(k) K190774

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190774↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190774 Date25 Jul 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RigidLoop Cortical Fixation System XL Implant is a surgical orthopedic device designed for internal fixation of bone fractures. It features a titanium button and a rigid loop mechanism to provide stable fixation, ensuring proper alignment and healing of cortical bone.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. The implant is classified under the Medical Device Regulation (MDR) and holds FDA 510(k) clearance as substantially equivalent to a predicate device, with a product code of MBI. Storage and handling must comply with sterile medical device protocols to maintain integrity.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RigidLoop Cortical Fixation System XL Implant primarily used for in surgical settings?

    The RigidLoop Cortical Fixation System XL Implant is designed specifically for internal fixation of bone fractures, ensuring stable alignment and proper healing of cortical bone during orthopedic surgeries. Its titanium button and rigid loop mechanism help maintain fixation throughout the recovery process.

  • Is the RigidLoop Cortical Fixation System XL Implant intended for reuse, or is it meant to be used only once?

    The device is explicitly labeled for single-use only, meaning it should not be reused after a surgical procedure. This ensures patient safety and maintains sterility, as required for orthopedic implants.

  • How should the RigidLoop Cortical Fixation System XL Implant be stored to preserve its sterility?

    Since the implant is supplied sterile, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until immediately before use and avoiding exposure to contamination or environmental conditions that could compromise its integrity.

  • What material is the RigidLoop Titanium Button made of, and why does this matter?

    The RigidLoop Titanium Button is made of titanium, a biocompatible material known for its strength, corrosion resistance, and compatibility with the human body. This makes it ideal for internal fixation, reducing the risk of adverse reactions while providing reliable structural support during bone healing.

  • What regulatory pathways has the RigidLoop Cortical Fixation System XL Implant followed, and how does this affect its use?

    The device holds FDA 510(k) clearance, meaning it was determined to be substantially equivalent to a predicate device through a traditional review process. It also complies with the Medical Device Regulation (MDR). These approvals confirm its safety and effectiveness for internal fixation of bone fractures, allowing clinicians to rely on it for orthopedic procedures with confidence.