Cleared Special

K153378 - Monster BITE Screw System

K153378 is the FDA 510(k) clearance for Monster BITE Screw System by Paragon 28. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 28-day FDA review.

K153378 · Paragon 28 · Orthopedic device
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Dec 2015
Decision
28d
Days
Class 2
Risk

K153378 is an FDA 510(k) clearance for the Monster BITE Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Paragon 28 (Englewood, US). The FDA issued a Cleared decision on December 21, 2015 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Paragon 28 devices

Submission Details

510(k) Number K153378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date December 21, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 568
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153378.
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
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