Cleared Traditional

K120570 - CHOICE SPINE VERTEBRAL BODY REPLACEMENT...

K120570 is the FDA 510(k) clearance for CHOICE SPINE VERTEBRAL BODY REPLACEMENT... by Choicespine, LP. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K120570 · Choicespine, LP · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2012
Decision
38d
Days
Class 2
Risk

K120570 is an FDA 510(k) clearance for the CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Choicespine, LP devices

Submission Details

510(k) Number K120570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2012
Decision Date April 05, 2012
Days to Decision 38 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 142
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K120570.
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · Medtronic Sofamor Danek, Inc. · Sep 2013
STAXX XD SYSTEM
K121889 · Spine Wave, Inc. · Aug 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
SANTORINI SPINAL SYSTEM
K111294 · K2m, Inc. · Jan 2012
STAXX(R) XD SYSTEM
K111418 · Spine Wave, Inc. · Dec 2011
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · Globus Medical, Inc. · Oct 2011