Cleared Traditional

K162439 - AxSOS 3 Ti

Also marketed or referenced as:
Stryker Plating System

K162439 is an FDA 510(k) clearance for AxSOS 3 Ti, manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K162439 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
156d
Days
Class 2
Risk

K162439 is an FDA 510(k) clearance for the AxSOS 3 Ti. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on February 3, 2017 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 GmbH devices

FDA 510(k) Submission Details - K162439

510(k) Number K162439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2016
Decision Date February 03, 2017
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K162439.
VariAx Distal Radius Plating System, VariAx 2 System
K162841 · Stryker GmbH · Feb 2017
APTUS® Coronoid 2.0
K161861 · Medartis AG · Feb 2017
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K163046 · DePuy Synthes · Feb 2017
dynaMX™ Compression Plate
K161303 · Mx Orthopedics, Corp. · Jan 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044 · Wrightmedicaltechnologyinc · Jan 2017
osteo-WEDGE II ® Open Wedge Bone Locking Plate System
K162179 · Graham Medical Technologies, LLC Dba Gramedica · Jan 2017