Cleared Special

K203011 - Monster Screw System

K203011 is the FDA 510(k) clearance for Monster Screw System by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 43-day FDA review.

K203011 · Paragon 28, Inc. · Orthopedic device
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Nov 2020
Decision
43d
Days
Class 2
Risk

K203011 is an FDA 510(k) clearance for the Monster Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on November 13, 2020 after a review of 43 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, Inc. devices

Submission Details

510(k) Number K203011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date November 13, 2020
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203011.
Arthrex Low Profile Screws
K203239 · Arthrex, Inc. · Dec 2020
WishBone Medical Plate and Screw System
K203467 · Wishbone Medical, Inc. · Dec 2020
CREED™ Cannulated Screws
K200291 · Glw Medical, Inc. · Dec 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
K202589 · Medartis AG · Nov 2020
GEO Bone Screw System
K202817 · Gramercy Extremity Orthopedics, LLC · Oct 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
K202680 · Osteomed, LLC · Oct 2020