Cleared Special

K130116 - SUPERIOR LATERAL VARIAX CLAVICLE PLATE

K130116 is an FDA 510(k) clearance for SUPERIOR LATERAL VARIAX CLAVICLE PLATE, manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 48-day FDA review.

K130116 · Stryker Trauma AG · Orthopedic device
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Mar 2013
Decision
48d
Days
Class 2
Risk

K130116 is an FDA 510(k) clearance for the SUPERIOR LATERAL VARIAX CLAVICLE PLATE. 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 March 5, 2013 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Trauma AG devices

FDA 510(k) Submission Details - K130116

510(k) Number K130116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date March 05, 2013
Days to Decision 48 days
Submission Type Special
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
Modification to existing cleared device.

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 K130116.
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · Stryker Trauma AG · Mar 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · Stryker Trauma AG · Mar 2013
AAP RADIUS SET 2.5
K123875 · Aap Implantate AG · Mar 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · CarboFix Orthopedics , Ltd. · Feb 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918 · Zimmer, Inc. · Feb 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · Smith & Nephew, Inc. · Jan 2013