Cleared Traditional

K140376 - VARIAX 2 SYSTEM

K140376 is an FDA 510(k) clearance for VARIAX 2 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 48-day FDA review.

K140376 · Stryker Trauma AG · Orthopedic device
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Apr 2014
Decision
48d
Days
Class 2
Risk

K140376 is an FDA 510(k) clearance for the VARIAX 2 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 April 3, 2014 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Trauma AG devices

FDA 510(k) Submission Details - K140376

510(k) Number K140376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date April 03, 2014
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 K140376.
PINIT SMALL BONE FUSION SYSTEM
K140617 · Arthrosurface, Inc. · Apr 2014
VARIAX 2 SYSTEM
K140769 · Stryker Trauma AG · Apr 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069 · Merete Medical GmbH · Apr 2014
VARIAX CLAVICLE HOOK PLATE
K140259 · Stryker Trauma AG · Apr 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · Osteomed LP · Feb 2014