Cleared Traditional

K173135 - VariAx 2 System

K173135 is the FDA 510(k) clearance for VariAx 2 System by Stryker GmbH. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K173135 · Stryker GmbH · Orthopedic device
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Nov 2017
Decision
59d
Days
Class 2
Risk

K173135 is an FDA 510(k) clearance for the VariAx 2 System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on November 27, 2017 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 GmbH devices

Submission Details

510(k) Number K173135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date November 27, 2017
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 573
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K173135.
G-Beam Fusion Beaming System
K172698 · Orthofix Srl · Feb 2018
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
Cannulated Screw Internal Fixation System
K173286 · Life Spine, Inc. · Dec 2017
Large Screws Range
K172596 · Newclip Technics · Oct 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017