Cleared Abbreviated

K140649 - VECTRIX EXTERNAL FIXATOR (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K140649 · 3D Medical Concepts, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
291d
Days
Class 2
Risk

K140649 is an FDA 510(k) clearance for the VECTRIX EXTERNAL FIXATOR. Classified as System, External Fixator (with Metallic Invasive Components) (product code NDK), Class II - Special Controls.

Submitted by 3D Medical Concepts, LLC (Pelham, US). The FDA issued a Cleared decision on December 29, 2014 after a review of 291 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all 3D Medical Concepts, LLC devices

Submission Details

510(k) Number K140649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2014
Decision Date December 29, 2014
Days to Decision 291 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 122d · This submission: 291d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NDK System, External Fixator (with Metallic Invasive Components)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.