Cleared Traditional

K133842 - TYBER MEDICAL TRAUMA SCREW

K133842 is an FDA 510(k) clearance for TYBER MEDICAL TRAUMA SCREW, manufactured by Tyber Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K133842 · Tyber Medical, LLC · Orthopedic device
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Mar 2014
Decision
92d
Days
Class 2
Risk

K133842 is an FDA 510(k) clearance for the TYBER MEDICAL 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 March 20, 2014 after a review of 92 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 Tyber Medical, LLC devices

FDA 510(k) Submission Details - K133842

510(k) Number K133842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date March 20, 2014
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 919
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K133842.
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · In2bones Sas · Apr 2014
PEEK FUSION IMPLANT
K133515 · Mtp Solutions, LLC · Mar 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · Extremity Medical, LLC · Mar 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · Wrightmedicaltechnologyinc · Mar 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
K140148 · Wrightmedicaltechnologyinc · Mar 2014
N-FORCE FIXATION SYSTEM
K132244 · Innovision, Inc. · Mar 2014