Cleared Traditional

K252901 - Tyber Medical Trauma Screw

K252901 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 111-day FDA review.

K252901 · Tyber Medical, LLC · Orthopedic device
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Dec 2025
Decision
111d
Days
Class 2
Risk

K252901 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 (Bethlehem, US). The FDA issued a Cleared decision on December 31, 2025 after a review of 111 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 - K252901

510(k) Number K252901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2025
Decision Date December 31, 2025
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K252901.
Tyber Medical Trauma Screw
K253042 · Tyber Medical, LLC · Apr 2026
DynaNail Mini
K254110 · MedShape, Inc. · Mar 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026
Ultra™ Compression Screw System
K251555 · Pace Surgical · Nov 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · Dev4 · Oct 2025
MetaFore Small Screw System
K250536 · Extremity Medical, LLC · Oct 2025