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Synthes Low Profile Neuro System

by Synthes (Usa) 510(k)

Active United States

510(k) K022012

Overview

The Synthes Low Profile Neuro System is a bone plate device designed for internal fixation. According to FDA classification (product code JEY), it falls under the category of 'Plate, Bone,' providing structural support for bone segments during the healing process in craniofacial and midface procedures. The system comprises titanium plates, meshes, and screws, engineered to offer low-profile integration with minimal soft-tissue disruption.

This system is intended for use in clinical or hospital settings by surgeons performing craniofacial or midface reconstructive procedures. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K022012) and classified as Class II with Special Controls. The system includes multiple titanium-based components, each identified by unique FEI numbers, and adheres to regulatory standards outlined in 21 CFR 872.4760. No sterility or single-use specifications are indicated in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022012 Date1 Nov 2002ClearedStatusActive

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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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Synthes Low Profile Neuro System used for?

    The Synthes Low Profile Neuro System is a bone plate device designed specifically for internal fixation in craniofacial and midface reconstructive procedures. It provides structural support to bone segments during the healing process, ensuring stability while minimizing soft-tissue disruption due to its low-profile titanium design.

  • Is the Synthes Low Profile Neuro System reusable or single-use?

    The Synthes Low Profile Neuro System is supplied as a reusable medical device. This classification aligns with its regulatory submission under FDA 510(k) clearance, where reuse is explicitly permitted for clinical use in hospital or surgical settings.

  • What materials are used in the Synthes Low Profile Neuro System?

    The system is composed entirely of titanium-based components. Titanium is chosen for its biocompatibility, strength, and ability to integrate well with bone tissue, reducing the risk of rejection or adverse reactions during long-term healing.

  • How many unique components does the system include, and how are they identified?

    The Synthes Low Profile Neuro System includes multiple titanium-based components, each identified by unique FEI (Federal Equipment Identifier) numbers. These numbers help clinicians and hospitals track inventory and ensure proper use of the correct parts during surgical procedures.

  • What regulatory standards apply to the Synthes Low Profile Neuro System?

    The system adheres to regulatory standards outlined in 21 CFR 872.4760, which governs bone plates and related fixation devices. It has received FDA 510(k) clearance (K022012) and is classified as a Class II medical device with Special Controls, ensuring it meets stringent safety and performance requirements for internal fixation applications.