Cleared Traditional

K192675 - VariAx Foot

K192675 is the FDA 510(k) clearance for VariAx Foot by Stryker GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K192675 · Stryker GmbH · Orthopedic device
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Nov 2019
Decision
57d
Days
Class 2
Risk

K192675 is an FDA 510(k) clearance for the VariAx Foot. 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 GmbH (Mahwah, US). The FDA issued a Cleared decision on November 22, 2019 after a review of 57 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 GmbH devices

Submission Details

510(k) Number K192675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date November 22, 2019
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 912
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K192675.
Avanti Distal Radius and Forearm System
K191118 · Avanti Orthopaedics, Inc. · Dec 2019
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
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Exsomed Wrist Plating System
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Axis Plating System
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K192323 · Fusion Orthopedics, LLC · Nov 2019
TDM Plate and Screw Systems
K190391 · Tdm Co., Ltd. · Nov 2019