Cleared Traditional

K183228 - HammerToe Compression System

K183228 is the FDA 510(k) clearance for HammerToe Compression System by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K183228 · Paragon 28, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
66d
Days
Class 2
Risk

K183228 is an FDA 510(k) clearance for the HammerToe Compression System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 66 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K183228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2018
Decision Date January 25, 2019
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 Peers - HTY Pin, Fixation, Smooth

All 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K183228.
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652 · OSSIO , Ltd. · Mar 2020
Hammertoe Truss System (HTS)
K190926 · 4Web, Inc. · Jul 2019
Arthrex DynaNite® PIP (Hammertoe) Implant
K190287 · Arthrex, Inc. · May 2019
OSSIO™ Pin Product Family
K181180 · OSSIO , Ltd. · Jan 2019
A.M. Surgical Intramedullary Fixation Device
K180087 · A.M. Surgical, Inc. · May 2018
HammerTube System
K171715 · Paragon 28 · Mar 2018