Cleared Traditional

Advanced LumFix Spinal Fixation System (K222229) - FDA 510(k) Clearance

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

K222229 · CG Bio Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
304d
Days
Class 2
Risk

K222229 is an FDA 510(k) clearance for the Advanced LumFix 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 CG Bio Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on May 25, 2023 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 CG Bio Co., Ltd. devices

Submission Details

510(k) Number K222229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date May 25, 2023
Days to Decision 304 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
182d slower than avg
Panel avg: 122d · This submission: 304d
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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K222229.
EDEN Spinal Fixation MIS System
K230762 · Jmt Co., Ltd. · Jun 2023
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
K222684 · Stryker Spine · Jun 2023
Dark Star Deformity Pedicle Screw System
K223096 · Republic Spine, LLC · May 2023
PressON Spinal Fixation System
K223529 · Nexus Spine, LLC · May 2023
ArtFX Spinal Fixation System
K212220 · Artfx Medical, LLC · Apr 2023
Altus Spine Monaco Pedicle Screw System
K230766 · Altus Spine · Apr 2023