Cleared Traditional

K181824 - CBT Screw Fixation System

K181824 is the FDA 510(k) clearance for CBT Screw Fixation System by U&I Corporation. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K181824 · U&I Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
157d
Days
Class 2
Risk

K181824 is an FDA 510(k) clearance for the CBT Screw 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 U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on December 13, 2018 after a review of 157 days - an extended review cycle.

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 U&I Corporation devices

Submission Details

510(k) Number K181824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date December 13, 2018
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K181824.
Pedimax II - Pedicular Screw Spinal System
K180626 · Gm Dos Reis Industria E Comerico Ltda. · Feb 2019
EUROPA™ Pedicle Screw System
K182970 · MiRus, LLC · Jan 2019
Whistler Modular Pedicle Screw System
K182478 · Evolution Spine, LLC · Jan 2019
LEUCADIA AUTOLOK™ Pedicle Screw System
K182339 · Clearview Orthopedic Development, LLC · Dec 2018
Salvo™ Spine System
K182954 · Spine Wave, Inc. · Dec 2018
OpenLoc-L Spinal Fixation System
K183168 · L & K Biomed Co., Ltd. · Dec 2018