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Vectrix External Fixator

by 3D Medical Concepts, LLC

510(k) K140649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK140649 Date29 Dec 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

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

The Vectrix External Fixator is a System, External Fixator (With Metallic Invasive Components), classified under FDA product code NDK. This orthopedic device is designed to stabilize and support long bone fractures or deformities by applying controlled external forces through metallic pins, wires, or screws affixed to the bone. It is engineered for modular assembly, allowing customization to fit various anatomical sites and clinical needs, including limb alignment and trauma management. The system’s construction ensures rigid fixation while minimizing soft tissue irritation.

The Vectrix External Fixator is supplied as a reusable, sterile device upon first use, intended for surgical application in controlled clinical settings such as orthopedic operating rooms or trauma centers. It is manufactured by 3D Medical Concepts, LLC and cleared under FDA 510(k) clearance (K140649) via the Abbreviated pathway, with a decision date of December 29, 2014. The device is MRI-unsafe due to its metallic components and must be stored in a clean, dry environment per manufacturer instructions. Sizes and configurations vary to accommodate pediatric through adult applications, as detailed in the accompanying technical documentation.