Cleared Special

K121615 - 4CIS VANE SPINE SYSTEM

K121615 is an FDA 510(k) clearance for 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 75-day FDA review.

K121615 · Solco Biomedical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
75d
Days
Class 2
Risk

K121615 is an FDA 510(k) clearance for the 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 August 15, 2012 after a review of 75 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. 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. Low regulatory complexity profile. 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 - K121615

510(k) Number K121615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date August 15, 2012
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 K121615.
S-LOK PSS SYSTEM
K122931 · Spinal USA · Nov 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012
CAPSURE(R) PS SYSTEM
K122233 · Spine Wave, Inc. · Oct 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · Spinal USA · Aug 2012
CAPSURE(R) PS SYSTEM
K120646 · Spine Wave, Inc. · Jun 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · K2m, Inc. · May 2012