Cleared Traditional

K170727 - VariAx 2 Compression Plating System

K170727 is the FDA 510(k) clearance for VariAx 2 Compression Plating System by Stryker GmbH. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K170727 · Stryker GmbH · Orthopedic device
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Jun 2017
Decision
105d
Days
Class 2
Risk

K170727 is an FDA 510(k) clearance for the VariAx 2 Compression Plating 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 GmbH (Mahwah, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 105 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 GmbH devices

Submission Details

510(k) Number K170727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2017
Decision Date June 22, 2017
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 915
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K170727.
ARIX Foot System (2.3/2.8)
K170780 · Jeil Medical Corporation · Aug 2017
ARIX Ankle Distal Tibia System
K170313 · Jeil Medical Corporation · Jul 2017
ARIX Diaphysis System
K171285 · Jeil Medical Corporation · Jul 2017
BioPro Foot Plating Systems
K162674 · Biopro, Inc. · Jun 2017
Alians Fragment Specific
K170843 · Newclip Technics · Jun 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · Smith & Nephew, Inc. · Jun 2017