Cleared Traditional

K192003 - Auxein Nailing System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192003 · Auxein Medical Private Limited · Orthopedic device
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Jun 2020
Decision
320d
Days
Class 2
Risk

K192003 is an FDA 510(k) clearance for the Auxein Nailing System. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on June 10, 2020 after a review of 320 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 Private Limited devices

Submission Details

510(k) Number K192003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2019
Decision Date June 10, 2020
Days to Decision 320 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
198d slower than avg
Panel avg: 122d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K192003.
TRIGEN Stable Lock Nut & Washer
K243608 · Smith & Nephew, Inc. · Jun 2025
TRIGEN MAX Tibial Nail System
K240061 · Smith & Nephew, Inc. · Sep 2024
TRIGEN INTERTAN 10S Nail System
K241804 · Smith & Nephew, Inc. · Aug 2024
NET BRAND Osteosynthesis Nailing System
K233150 · Narang Medical , Ltd. · Feb 2024
TRIGEN META-NAIL Nail System
K230761 · Smith & Nephew, Inc. · Jun 2023
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
K201336 · Synthes USA Products, LLC · Sep 2020