Cleared Traditional

K171715 - HammerTube System

K171715 is the FDA 510(k) clearance for HammerTube System by Paragon 28. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K171715 · Paragon 28 · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
269d
Days
Class 2
Risk

K171715 is an FDA 510(k) clearance for the HammerTube System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Paragon 28 (Englewood, US). The FDA issued a Cleared decision on March 5, 2018 after a review of 269 days - an extended review 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: 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 Paragon 28 devices

Submission Details

510(k) Number K171715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2017
Decision Date March 05, 2018
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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

Backroads Consulting, Inc.
Karen E. Warden

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 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K171715.
HammerToe Compression System
K183228 · Paragon 28, Inc. · Jan 2019
OSSIO™ Pin Product Family
K181180 · OSSIO , Ltd. · Jan 2019
A.M. Surgical Intramedullary Fixation Device
K180087 · A.M. Surgical, Inc. · May 2018
Footmotion HammerToe
K172485 · Newclip Technics · Mar 2018
DIP Arthrodesis System
K173616 · In2bones Sas · Jan 2018
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K173051 · Orthofix Srl · Nov 2017