Cleared Traditional

K181091 - AxSOS 3 Ti

K181091 is the FDA 510(k) clearance for AxSOS 3 Ti by Stryker GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K181091 · Stryker GmbH · Orthopedic device
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Oct 2018
Decision
170d
Days
Class 2
Risk

K181091 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 (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on October 11, 2018 after a review of 170 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

Submission Details

510(k) Number K181091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2018
Decision Date October 11, 2018
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K181091.
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K182492 · Skeletal Dynamics, LLC · Oct 2018
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K181587 · Tornier, Inc. · Oct 2018