Cleared Traditional

K124027 - MONSTER SCREW SYSTEM

K124027 is an FDA 510(k) clearance for MONSTER SCREW SYSTEM, manufactured by Apogee Orthosolutions. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K124027 · Apogee Orthosolutions · Orthopedic device
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Apr 2013
Decision
98d
Days
Class 2
Risk

K124027 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 Apogee Orthosolutions (Chesterland, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 98 days - within the typical 510(k) review window.

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 Apogee Orthosolutions devices

FDA 510(k) Submission Details - K124027

510(k) Number K124027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2012
Decision Date April 05, 2013
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HWC Screw, Fixation, Bone

All 758
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K124027.
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013
AAP CANNULATED SCREW 2.0
K130590 · Aap Implantate AG · Apr 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120 · Extremity Medical, LLC · Apr 2013
MERETEC CS, CORTICAL SCREWS
K130400 · Merete Medical GmbH · Apr 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · Acumed, LLC · Mar 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · Depuy Mitek, A Johnson & Johnson Company · Feb 2013