Cleared Traditional

K123403 - AXSOS PROXIMAL LATERAL TIBIA LONG PLATES

K123403 is an FDA 510(k) clearance for AXSOS PROXIMAL LATERAL TIBIA LONG PLATES, manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K123403 · Stryker Trauma AG · Orthopedic device
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Mar 2013
Decision
135d
Days
Class 2
Risk

K123403 is an FDA 510(k) clearance for the AXSOS PROXIMAL LATERAL TIBIA LONG PLATES. 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 Trauma AG (Mahwah, US). The FDA issued a Cleared decision on March 20, 2013 after a review of 135 days - within the typical 510(k) review window.

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 Trauma AG devices

FDA 510(k) Submission Details - K123403

510(k) Number K123403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date March 20, 2013
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123403.
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