Cleared Special

K081145 - MODIFICATION TO 4CIS VANE SPINE SYSTEM

K081145 is an FDA 510(k) clearance for MODIFICATION TO 4CIS VANE SPINE SYSTEM, manufactured by Solco Biomedical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 197-day FDA review.

K081145 · Solco Biomedical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2008
Decision
197d
Days
Class 2
Risk

K081145 is an FDA 510(k) clearance for the MODIFICATION TO 4CIS VANE SPINE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Solco Biomedical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on November 5, 2008 after a review of 197 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solco Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K081145

510(k) Number K081145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2008
Decision Date November 05, 2008
Days to Decision 197 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 185
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K081145.
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008
COSMIC SYSTEM
K080841 · Ulrich GmbH & Co. KG · Jul 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008
CONQUEST SPINAL SYSTEM
K080767 · Life Spine · May 2008