Cleared Traditional

K181091 - AxSOS 3 Ti

K181091 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 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

FDA 510(k) Submission Details - K181091

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.

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 1235
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K181091.
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