Cleared Special

4CIS® Chiron Spinal Fixation System (K231655) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231655 · Solco Biomedical Co., Ltd. · Orthopedic device
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Nov 2024
Decision
539d
Days
Class 2
Risk

K231655 is an FDA 510(k) clearance for the 4CIS® Chiron 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 Solco Biomedical Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on November 26, 2024 after a review of 539 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Solco Biomedical Co., Ltd. devices

Submission Details

510(k) Number K231655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2023
Decision Date November 26, 2024
Days to Decision 539 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
417d slower than avg
Panel avg: 122d · This submission: 539d
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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K231655.
NEO Pedicle Screw System™
K243693 · Neo Medical SA · Dec 2024
Reform Pedicle Screw System
K242297 · Precision Spine, Inc. · Dec 2024
LOCK-IN Spinal Fixation System
K243281 · Lock-In USA Corp · Dec 2024
MediRod Pedicle Screw System
K242764 · Cmf Medicon Surgical, Inc. · Nov 2024
Xpine Spinal Fixation System
K243004 · Jeil Medical Corporation · Nov 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · CarboFix Orthopedics , Ltd. · Nov 2024