Cleared Traditional

K170418 - Stryker SonicPin System

K170418 is an FDA 510(k) clearance for Stryker SonicPin System, manufactured by Stryker Trauma GmbH. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K170418 · Stryker Trauma GmbH · Orthopedic device
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Jun 2017
Decision
127d
Days
Class 2
Risk

K170418 is an FDA 510(k) clearance for the Stryker SonicPin System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Schoenkirchen, DE). The FDA issued a Cleared decision on June 20, 2017 after a review of 127 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 Stryker Trauma GmbH devices

FDA 510(k) Submission Details - K170418

510(k) Number K170418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date June 20, 2017
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K170418.
WishBone K-Wire System
K173013 · Wishbone Medical, Inc. · Dec 2017
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K173051 · Orthofix Srl · Nov 2017
dynaMX Intramedullary Implant
K170326 · Arthrex, Inc. · Jul 2017
Precifit Medical Kirschner Wires
K163327 · Precifit Medical, Ltd. · May 2017
Syntorr K-wire and Pin System
K161489 · Syntorr, Inc. · Sep 2016
Additive Orthopaedics Hammertoe Correction System
K160264 · Additive Orthopaedics, LLC · Jun 2016