Cleared Traditional

K150211 - EzFuze Implant System

K150211 is the FDA 510(k) clearance for EzFuze Implant System by Vilex IN Tennessee, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K150211 · Vilex IN Tennessee, Inc. · Orthopedic device
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Nov 2015
Decision
284d
Days
Class 2
Risk

K150211 is an FDA 510(k) clearance for the EzFuze Implant System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on November 10, 2015 after a review of 284 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 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 Vilex IN Tennessee, Inc. devices

Submission Details

510(k) Number K150211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date November 10, 2015
Days to Decision 284 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
162d slower than avg
Panel avg: 122d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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.

Regulatory Peers - HWC Screw, Fixation, Bone

All 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150211.
Large Screws Range
K160617 · Newclip Technics · Jun 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
ForeFoot STP System
K150871 · Tornier, Inc. · Aug 2015
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015