Cleared Traditional

K201715 - Smart Toe II

K201715 is the FDA 510(k) clearance for Smart Toe II by Stryker GmbH. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K201715 · Stryker GmbH · Orthopedic device
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Aug 2020
Decision
43d
Days
Class 2
Risk

K201715 is an FDA 510(k) clearance for the Smart Toe II, X Fuse. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on August 5, 2020 after a review of 43 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 Stryker GmbH devices

Submission Details

510(k) Number K201715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2020
Decision Date August 05, 2020
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 K201715.
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Arthrex DynaNite K-Wire
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OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652 · OSSIO , Ltd. · Mar 2020
Hammertoe Truss System (HTS)
K190926 · 4Web, Inc. · Jul 2019