Cleared Special

K153180 - Tyber Medical MST Trauma Screw

K153180 is an FDA 510(k) clearance for Tyber Medical MST Trauma Screw, manufactured by Tyber Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 22-day FDA review.

K153180 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2015
Decision
22d
Days
Class 2
Risk

K153180 is an FDA 510(k) clearance for the Tyber Medical MST Trauma Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Morristown, US). The FDA issued a Cleared decision on November 25, 2015 after a review of 22 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 Tyber Medical, LLC devices

FDA 510(k) Submission Details - K153180

510(k) Number K153180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2015
Decision Date November 25, 2015
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 Peers - HWC Screw, Fixation, Bone

All 951
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153180.
Tiger Cannulated Screw System
K153338 · Trilliant Surgical, Ltd. · Jan 2016
Asnis JFX System
K153154 · Stryker Trauma AG · Dec 2015
Monster BITE Screw System
K153378 · Paragon 28 · Dec 2015
SELF- COMPRESSIVE SCREW
K153182 · Neosteo · Nov 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
EzFuze Implant System
K150211 · Vilex IN Tennessee, Inc. · Nov 2015