Cleared Traditional

K172485 - Footmotion HammerToe

K172485 is an FDA 510(k) clearance for Footmotion HammerToe, manufactured by Newclip Technics. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K172485 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
197d
Days
Class 2
Risk

K172485 is an FDA 510(k) clearance for the Footmotion HammerToe. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on March 2, 2018 after a review of 197 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 Newclip Technics devices

FDA 510(k) Submission Details - K172485

510(k) Number K172485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2017
Decision Date March 02, 2018
Days to Decision 197 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

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 163
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K172485.
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
DIP Arthrodesis System
K173616 · In2bones Sas · Jan 2018
WishBone K-Wire System
K173013 · Wishbone Medical, Inc. · Dec 2017
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K173051 · Orthofix Srl · Nov 2017