Cleared Traditional

K172548 - Wiltrom Spinal Fixation System

K172548 is the FDA 510(k) clearance for Wiltrom Spinal Fixation System by Wiltrom Corporation Limited. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K172548 · Wiltrom Corporation Limited · Orthopedic device
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Jan 2018
Decision
142d
Days
Class 2
Risk

K172548 is an FDA 510(k) clearance for the Wiltrom Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Wiltrom Corporation Limited (Zhubei City, TW). The FDA issued a Cleared decision on January 12, 2018 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Wiltrom Corporation Limited devices

Submission Details

510(k) Number K172548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2017
Decision Date January 12, 2018
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172548.
SEURAT™ Universal Pedicle Screw System
K173185 · Ctl Medical Corporation · Feb 2018
SeaSpine Mariner Pedicle Screw System
K173882 · SeaSpine Orthopedics Corporation · Feb 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · Degen Medical · Jan 2018
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K171421 · Silony Medical GmbH · Jan 2018
Everest Spinal System
K173508 · K2m · Jan 2018
Solanas® Posterior Stabilization System
K173522 · Alphatec Spine, Inc. · Nov 2017