Cleared Special

K071497 - ATLAS SPINE VERTEBRAL BODY REPLACEMENT

K071497 is an FDA 510(k) clearance for ATLAS SPINE VERTEBRAL BODY REPLACEMENT, manufactured by Atlas Spine, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 29-day FDA review.

K071497 · Atlas Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2007
Decision
29d
Days
Class 2
Risk

K071497 is an FDA 510(k) clearance for the ATLAS SPINE VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 29 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. 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 Atlas Spine, Inc. devices

FDA 510(k) Submission Details - K071497

510(k) Number K071497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2007
Decision Date June 29, 2007
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

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 190
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K071497.
LDR SPINE ROI-T SYSTEM
K072132 · Ldr Spine USA · Aug 2007
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · Theken Spine, LLC · Jul 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · Theken Spine, LLC · Jun 2007
THEKEN VU MESH VBR SYSTEM
K070381 · Theken Spine, LLC · Apr 2007
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007