Cleared Traditional

K123964 - AXSOS 3 TI LOCKING PLATE SYSTEM

K123964 is an FDA 510(k) clearance for AXSOS 3 TI LOCKING PLATE SYSTEM, 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 92-day FDA review.

K123964 · Stryker Trauma AG · Orthopedic device
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Mar 2013
Decision
92d
Days
Class 2
Risk

K123964 is an FDA 510(k) clearance for the AXSOS 3 TI LOCKING PLATE SYSTEM. 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 28, 2013 after a review of 92 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 - K123964

510(k) Number K123964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date March 28, 2013
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 K123964.
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093 · Wrightmedicaltechnologyinc · May 2013
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K123241 · Arthrex, Inc. · Apr 2013
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
K122770 · Biomet Manufacturing Corp · Mar 2013
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · Stryker Trauma AG · Mar 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · Stryker Trauma AG · Mar 2013
AAP RADIUS SET 2.5
K123875 · Aap Implantate AG · Mar 2013