Cleared Traditional

K141680 - AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 1312
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141680.
Medline Foot Plates and Screws
K151235 · Medline Industries, Inc. · Aug 2015
VariAx 2 One-Third Tubular Plating System
K151879 · Stryker GmbH · Aug 2015
Metallic Locking Bone Plate and Screw
K142943 · Canwell Medical Co., Ltd. · Aug 2015
VariAx 2 Wrist Fusion System
K151178 · Stryker Trauma AG · Jun 2015
APTUS Wrist 2.5 System
K142906 · Medartis AG · Jun 2015
Metallic Locking Bone Plate and Screw System
K143002 · Changzhou Dingjian Medical Appliance Co., Ltd. · Jun 2015