Cleared Special

K051000 - FORTITUDE VUE VERTEBRAL BODY REPLACEMEN...

K051000 is the FDA 510(k) clearance for FORTITUDE VUE VERTEBRAL BODY REPLACEMEN... by Spinal Concepts, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 29-day FDA review.

K051000 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
29d
Days
Class 2
Risk

K051000 is an FDA 510(k) clearance for the FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on May 19, 2005 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 Spinal Concepts, Inc. devices

Submission Details

510(k) Number K051000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2005
Decision Date May 19, 2005
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K051000.
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005
PEEK CAS
K050861 · Interpore Cross Intl. · May 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005