Cleared Traditional

K141680 - AUXEIN BRAND OF Bone Plates and Bone Sc...

K141680 is an FDA 510(k) clearance for AUXEIN BRAND OF Bone Plates and Bone Sc..., manufactured by Auxein Medical. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K141680 · Auxein Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
372d
Days
Class 2
Risk

K141680 is an FDA 510(k) clearance for the AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate Syste.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Auxein Medical (New Delhi, IN). The FDA issued a Cleared decision on June 30, 2015 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Auxein Medical devices

FDA 510(k) Submission Details - K141680

510(k) Number K141680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date June 30, 2015
Days to Decision 372 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 122d · This submission: 372d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141680.
Arthrex Fracture Plates
K151732 · Arthrex, Inc. · Aug 2015
Medline Foot Plates and Screws
K151235 · Medline Industries, Inc. · Aug 2015
VariAx 2 One-Third Tubular Plating System
K151879 · Stryker GmbH · Aug 2015
VariAx 2 Wrist Fusion System
K151178 · Stryker Trauma AG · Jun 2015
APTUS Wrist 2.5 System
K142906 · Medartis AG · Jun 2015
Piccolo Composite Plate System
K143496 · CarboFix Orthopedics , Ltd. · May 2015