Cleared Traditional

K153379 - AxSOS 3Ti

K153379 is an FDA 510(k) clearance for AxSOS 3Ti, 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 185-day FDA review.

K153379 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
185d
Days
Class 2
Risk

K153379 is an FDA 510(k) clearance for the AxSOS 3Ti. 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 (Selzach, CH). The FDA issued a Cleared decision on May 26, 2016 after a review of 185 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 - K153379

510(k) Number K153379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date May 26, 2016
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
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 1305
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153379.
Conventus Orthopaedics Ulna Fixation System
K161048 · Conventus Orthopaedics, Inc. · Jul 2016
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
K153374 · Orthocare · Jun 2016
NEOVIEW Plating System
K160995 · In2bones Sas · Jun 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · Osteomed · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716 · Gpc Medical, Ltd. · May 2016