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Cranial Loop, Cranial Loop L and Cranial Loop Xl and Cranial Bone Fixation System

by Neos Surgery S.L 510(k)

Active United States

510(k) K132044

Overview

The Cranial Loop Cranial Bone Fixation System is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps resulting from craniotomies. It is completely instrument-free due to its fast and easy 'Pull and tighten' action, which allows the surgeon to fixate a standard bone flap in less than a minute with only three steps.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only. These are long-term implantable devices indicated for post-craniotomy bone flap fixation, with FDA 510(k) clearance.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132044 Date30 Sep 2013ClearedStatusActive

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
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  • 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
GXR
Device Class
Class II
Regulation
21 CFR Part 882.5250
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Neos Surgery S.L

Questions

  • What is the Cranial Loop Bone Fixation System used for?

    The Cranial Loop is a biocompatible PEEK-OPTIMA™ system designed for securely fixing bone flaps resulting from craniotomies. It's available in three models: Cranial LOOP (FC050000), Cranial LOOP (L) (FC050100) for use within the osteotomy line, and Cranial LOOP (XL) (FC050200) specifically for covering standard 14 mm cranial burr holes.

  • How is the Cranial Loop system applied during surgery?

    The Cranial Loop system is completely instrument-free, featuring a fast and easy 'Pull and tighten' action that allows surgeons to fixate a standard bone flap in less than a minute with just three simple steps, making the procedure efficient and straightforward.

  • What is the Cranial Loop made of and is it reusable?

    The Cranial Loop is made of PEEK-OPTIMA™, a biocompatible polymer material. It is designed as a long-term implantable device for post-craniotomy bone flap fixation, with each unit intended for single-use to ensure sterility and optimal performance.

  • What regulatory approvals does the Cranial Loop have?

    The Cranial Loop Bone Fixation System has FDA 510(k) clearance with the K-number K132044, classified as substantially equivalent under product code GXR. It is indicated for post-craniotomy bone flap fixation and has clearance for use in neurology procedures.