Cleared Traditional

Eleganz Fusion Screw System (Fusion Screw System) (K250251) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250251 · Dev4 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
136d
Days
Class 2
Risk

K250251 is an FDA 510(k) clearance for the Eleganz Fusion Screw System (Fusion Screw System). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Dev4 (Houston, US). The FDA issued a Cleared decision on June 13, 2025 after a review of 136 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 Dev4 devices

Submission Details

510(k) Number K250251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2025
Decision Date June 13, 2025
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 Consultant

Omedtech, LLC
Lance Terrill

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K250251.
CurvaFix Low Profile System
K252019 · Curvafix, Inc. · Aug 2025
Phoenix Sinus Tarsi Stent System
K251382 · Astra Orthomed, Inc. · Aug 2025
Dunamis Screw and Suture Locking System
K250867 · Dunamis Medical, LLC · Aug 2025
TriMed® Compression Screws
K243943 · TriMed, Inc. · Apr 2025
SnapHammer Hammertoe Correction System
K250613 · Nvision Biomedical Technologies, Inc. · Apr 2025
TITANEX Screw Systems
K250304 · Vilex, LLC · Mar 2025