Cleared Traditional

K192975 - Tyber Medical Trauma Screws

K192975 is the FDA 510(k) clearance for Tyber Medical Trauma Screws by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K192975 · Tyber Medical, LLC · Orthopedic device
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Jan 2020
Decision
77d
Days
Class 2
Risk

K192975 is an FDA 510(k) clearance for the Tyber Medical Trauma Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on January 9, 2020 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tyber Medical, LLC devices

Submission Details

510(k) Number K192975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2019
Decision Date January 09, 2020
Days to Decision 77 days
Submission Type Traditional
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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 565
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K192975.
Omnia Medical Trauma Screws
K192096 · Omnia Medical, LLC · Feb 2020
Titanium Interference Screws
K193451 · Biomet, Inc. · Feb 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156 · Arthrex, Inc. · Feb 2020
Tyber Medical Trauma Screw
K192974 · Tyber Medical, LLC · Jan 2020
InCore TMT System
K192578 · Nextremity Solutions, Inc. · Dec 2019
ARIX Cannulated Screw System
K192417 · Jeil Medical Corporation · Nov 2019