Cleared Traditional

K143063 - Stryker SonicPin System

K143063 is the FDA 510(k) clearance for Stryker SonicPin System by Stryker Trauma GmbH. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K143063 · Stryker Trauma GmbH · Orthopedic device
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Jan 2015
Decision
95d
Days
Class 2
Risk

K143063 is an FDA 510(k) clearance for the Stryker SonicPin System, Stryker SonicAnchor System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Mahwah, US). The FDA issued a Cleared decision on January 27, 2015 after a review of 95 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

Submission Details

510(k) Number K143063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2014
Decision Date January 27, 2015
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 97
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K143063.
ProCinch Adjustable Loop Device
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K143702 · Arthrex, Inc. · Apr 2015
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K143618 · Zimmer, Inc. · Feb 2015
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · Wrightmedicaltechnologyinc · Oct 2014
ARTHREX PIP DART
K141577 · Arthrex, Inc. · Jul 2014
WMT IMPLANTABLE K-WIRE
K132895 · Wrightmedicaltechnologyinc · Oct 2013