Cleared Traditional

Auxein Brand Vertaux 5.5 mm Pedicle Screw System (K201457) - FDA 510(k) Clearance

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

K201457 · Auxein Medical Private Limited/71164 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
309d
Days
Class 2
Risk

K201457 is an FDA 510(k) clearance for the Auxein Brand Vertaux 5.5 mm Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Auxein Medical Private Limited/71164 (Sonipat, IN). The FDA issued a Cleared decision on April 6, 2021 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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/71164 devices

Submission Details

510(k) Number K201457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date April 06, 2021
Days to Decision 309 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
187d slower than avg
Panel avg: 122d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K201457.
M.U.S.T. Midline Cortical (MC) Screw System
K210427 · Medacta International S.A. · Apr 2021
Goblin and Goblin LS Pedicle Screw Systems
K210420 · Medynus, Inc. · Apr 2021
CoreLink Midline Fixation System
K210539 · Corelink, LLC · Apr 2021
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
K210716 · CarboFix Orthopedics , Ltd. · Apr 2021
Polaris Spinal System
K210275 · Zimmer Biomet Spine, Inc. · Apr 2021
Republic Spine Dark Star Spinal System
K201420 · Republic Spine, LLC · Mar 2021