Cleared Traditional

K192003 - Auxein Nailing System

K192003 is an FDA 510(k) clearance for Auxein Nailing System, manufactured by Auxein Medical Private Limited. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K192003 · Auxein Medical Private Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K192003

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
Combination Product No
PCCP Authorized No
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.

JDS Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K192003.
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
WIN Flexible Nail System
K193533 · Biomet, Inc. · Feb 2020
CHINA NAILS AND ACCESSORIES
K123948 · Smith & Nephew, Inc. · Mar 2013
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · Synthes (Usa) · Dec 2011