Cleared Special

Auxein Nailing System (K210792) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210792 · Auxein Medical Private Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
163d
Days
Class 2
Risk

K210792 is an FDA 510(k) clearance for the Auxein Nailing System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on August 25, 2021 after a review of 163 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Auxein Medical Private Limited devices

Submission Details

510(k) Number K210792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date August 25, 2021
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 415
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K210792.
Treace Medical Concepts (TMC) Screw Fixation System
K213036 · Treace Medical Concepts, Inc. · Oct 2021
ChM 4.5mm Cortical screws
K210490 · Chm Sp. Z O.O. · Oct 2021
Nexta PEEK Hammertoe Correction System
K211996 · Nextremity Solutions, Inc. · Sep 2021
Auxilock Titanium Interference Screw
K203029 · Auxein Medical Private Limited · Aug 2021
PAO Cortical Screw
K211435 · Medacta International S.A. · Aug 2021
TriMed Threaded Intramedullary Nail System
K211783 · TriMed, Inc. · Aug 2021