Cleared Traditional

Hammertoe Truss System (HTS) (K221283) - FDA 510(k) Clearance

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

K221283 · 4Web Medical, Inc. · Orthopedic device
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Sep 2022
Decision
126d
Days
Class 2
Risk

K221283 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 Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on September 6, 2022 after a review of 126 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 Medical, Inc. devices

Submission Details

510(k) Number K221283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2022
Decision Date September 06, 2022
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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
Richard 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 70
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K221283.
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SECURE-LOCK
K220906 · Xiros, Ltd. · Jul 2022
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
K213982 · Pacific Instruments · Feb 2022
restor3d Pin Implants
K211789 · Restor3d · Jan 2022