Cleared Traditional

K043578 - THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM

K043578 is an FDA 510(k) clearance for THE 4CIS SPINAL SYSTEM AND 4CIS LOW BAC..., manufactured by Solco Biomedical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K043578 · Solco Biomedical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
69d
Days
Class 2
Risk

K043578 is an FDA 510(k) clearance for the THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Solco Biomedical Co., Ltd. (Bethesda, US). The FDA issued a Cleared decision on March 7, 2005 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solco Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K043578

510(k) Number K043578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2004
Decision Date March 07, 2005
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 200
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K043578.
GSS PEDICLE SCREW SYSTEM
K053573 · GS Medical Co., Ltd. · Mar 2006
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · Solco Biomedical Co., Ltd. · May 2005
STRYKER SPINE TRIO PS
K043180 · Stryker Spine · Mar 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · Medtronic Sofamor Danek · Dec 2004
PROTEX STABILIZATION SYSTEM
K040442 · Globus Medical, Inc. · May 2004