Cleared Traditional

Hammertoe Truss System (HTS) (K190926) - FDA 510(k) Clearance

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

K190926 · 4Web, Inc. · Orthopedic device
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Jul 2019
Decision
105d
Days
Class 2
Risk

K190926 is an FDA 510(k) clearance for the Hammertoe Truss System (HTS). Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on July 23, 2019 after a review of 105 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 4Web, Inc. devices

Submission Details

510(k) Number K190926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2019
Decision Date July 23, 2019
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
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

Silver Pine Consulting, LLC
Rich Jansen

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 - HTY Pin, Fixation, Smooth

All 68
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K190926.
Smart Toe II, X Fuse
K201715 · Stryker GmbH · Aug 2020
Arthrex DynaNite K-Wire
K200068 · Arthrex, Inc. · Jun 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652 · OSSIO , Ltd. · Mar 2020
Arthrex DynaNite® PIP (Hammertoe) Implant
K190287 · Arthrex, Inc. · May 2019
HammerToe Compression System
K183228 · Paragon 28, Inc. · Jan 2019
OSSIO™ Pin Product Family
K181180 · OSSIO , Ltd. · Jan 2019