Cleared Special

K202894 - Wiltrom Spinal Fixation System

K202894 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 Special 510(k) pathway after a 25-day FDA review.

K202894 · Wiltrom Corporation Limited · Orthopedic device
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Oct 2020
Decision
25d
Days
Class 2
Risk

K202894 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 October 23, 2020 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wiltrom Corporation Limited devices

Submission Details

510(k) Number K202894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date October 23, 2020
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K202894.
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K202771 · Medtronic · Oct 2020