Cleared Traditional

Gexfix External Fixation (K160972) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160972 · Gexfix International Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
266d
Days
Class 2
Risk

K160972 is an FDA 510(k) clearance for the Gexfix External Fixation. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Gexfix International Corp. (Boca Raton, US). The FDA issued a Cleared decision on December 28, 2016 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Gexfix International Corp. devices

Submission Details

510(k) Number K160972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2016
Decision Date December 28, 2016
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K160972.
SALVATION External Fixation System
K180832 · Wrightmedicaltechnologyinc · Jun 2018
DePuy Synthes Femoral Neck System
K172872 · DePuy Synthes · Mar 2018
ARBOR External Fixation System
K172438 · Globus Medical, Inc. · Jan 2018
SALVATION(R) External Fixation System
K153635 · Wrightmedicaltechnologyinc · Jan 2016
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
K151907 · Zimmer, Inc. · Dec 2015
FastFrame External Fixation System-Ankle Spanning
K152755 · Zimmer, Inc. · Dec 2015