Cleared Traditional

K180500 - VariAx 2 System

K180500 is an FDA 510(k) clearance for VariAx 2 System, manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K180500 · Stryker GmbH · Orthopedic device
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Jun 2018
Decision
98d
Days
Class 2
Risk

K180500 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 June 4, 2018 after a review of 98 days - within the typical 510(k) review window.

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: 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 - K180500

510(k) Number K180500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2018
Decision Date June 04, 2018
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 939
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180500.
Injection Screw
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Fracture and Correction System
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Diamond Orthopedic Bone Fixation Screws and Pins
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InCore® Lapidus System
K180257 · Nextremity Solutions, Inc. · Apr 2018
SafetyFix EasyOut System
K180753 · Safetyfix Medical Technologies, Inc. · Apr 2018