Cleared Traditional

K140259 - VARIAX CLAVICLE HOOK PLATE

K140259 is an FDA 510(k) clearance for VARIAX CLAVICLE HOOK PLATE, manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K140259 · Stryker Trauma AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
57d
Days
Class 2
Risk

K140259 is an FDA 510(k) clearance for the VARIAX CLAVICLE HOOK 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 April 1, 2014 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 Trauma AG devices

FDA 510(k) Submission Details - K140259

510(k) Number K140259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date April 01, 2014
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.

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 K140259.
VARIAX 2 SYSTEM
K140769 · Stryker Trauma AG · Apr 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069 · Merete Medical GmbH · Apr 2014
VARIAX 2 SYSTEM
K140376 · Stryker Trauma AG · Apr 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · Osteomed LP · Feb 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · Smith & Nephew, Inc. · Feb 2014