Cleared Traditional

K143110 - GALAXY MIS Screw System

K143110 is an FDA 510(k) clearance for GALAXY MIS Screw System, manufactured by Bm Korea. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K143110 · Bm Korea · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
238d
Days
Class 2
Risk

K143110 is an FDA 510(k) clearance for the GALAXY MIS 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 Bm Korea (Gunpo-Si, KR). The FDA issued a Cleared decision on June 24, 2015 after a review of 238 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 Bm Korea devices

FDA 510(k) Submission Details - K143110

510(k) Number K143110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2014
Decision Date June 24, 2015
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K143110.
Nautilus Spinal System
K151196 · Life Spine, Inc. · Jul 2015
Reform Pedicle Screw System
K150856 · Precision Spine, Inc. · Jul 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · Orthofix, Inc. · Jul 2015
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
K142752 · Zimmer Spine, Inc. · Jun 2015
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835 · Medyssey USA, Inc. · Jun 2015
Mercury Spinal System
K151215 · Spinal Elements, Inc. · Jun 2015