Cleared Traditional

Wiltrom Spinal Fixation System (K172548) - FDA 510(k) Clearance

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

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 898
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172548.
Varion Thoracolumbar Fixation System
K260989 · Kyocera Medical Technologies Inc. (KMTI) · May 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
K253739 · Globus Medical, Inc. · May 2026
AccelFix Spinal Fixation System
K261130 · L & K Biomed Co., Ltd. · May 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
LEO Spinal System
K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · Medacta International S.A. · Apr 2026