Cleared Special

K153378 - Monster BITE Screw System

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

K153378 · Paragon 28 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K153378

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

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 Consultant

Backroads Consulting, Inc.
Karen E. Warden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 942
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153378.
Epic Extremity Cannulated Screw System
K153333 · Epic Extremity, LLC · Jan 2016
Tiger Cannulated Screw System
K153338 · Trilliant Surgical, Ltd. · Jan 2016
Asnis JFX System
K153154 · Stryker Trauma AG · Dec 2015
Tyber Medical MST Trauma Screw
K153180 · Tyber Medical, LLC · Nov 2015
SELF- COMPRESSIVE SCREW
K153182 · Neosteo · Nov 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015