Cleared Traditional

K153575 - Tyber Medical Trauma Screw

K153575 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 73-day FDA review.

K153575 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
73d
Days
Class 2
Risk

K153575 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 February 26, 2016 after a review of 73 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

FDA 510(k) Submission Details - K153575

510(k) Number K153575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date February 26, 2016
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 958
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153575.
SMV Scientific Schanz Screws
K160603 · Smv Scientific · Mar 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
RECON system - Compression Screws
K151708 · Normed Medizin-Technik GmbH · Mar 2016
SIGN Compression Screw System
K153759 · Sign Fracture Care International · Feb 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
K152187 · Merete Medical GmbH · Feb 2016
MINIARS SCREWS
K143596 · Overmed Srl. · Feb 2016