Cleared Special

K151418 - Monster Screw System

K151418 is an FDA 510(k) clearance for Monster 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 48-day FDA review.

K151418 · Paragon 28 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
48d
Days
Class 2
Risk

K151418 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 (Englewood, US). The FDA issued a Cleared decision on July 15, 2015 after a review of 48 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 - K151418

510(k) Number K151418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2015
Decision Date July 15, 2015
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 K151418.
ForeFoot STP System
K150871 · Tornier, Inc. · Aug 2015
N-Force Fixation System
K151146 · Innovision, Inc. · Jul 2015
OsteoMed Cannulated Screw System
K151021 · Osteomed Corp. · Jul 2015
SMV Scientific Bone Screws
K150981 · Smv Scientific · Jun 2015
Sonoma Cancellous Bone Screw and Washer
K150376 · Sonoma Orthopedics Products, Inc. · Jun 2015
ToeTac Hammertoe Fixation System
K150443 · Restore Surgical, LLC Dba Instratek · Jun 2015