Cleared Special

K071921 - INNOVASIS EXCELLA SPINAL SYSTEM

K071921 is the FDA 510(k) clearance for INNOVASIS EXCELLA SPINAL SYSTEM by Innovasis, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 127-day FDA review.

K071921 · Innovasis, Inc. · Orthopedic device
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Nov 2007
Decision
127d
Days
Class 2
Risk

K071921 is an FDA 510(k) clearance for the INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POL.... Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 127 days - within the typical 510(k) review window.

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 Innovasis, Inc. devices

Submission Details

510(k) Number K071921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2007
Decision Date November 16, 2007
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K071921.
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007
EXPEDIUM SPINE SYSTEM
K073126 · Depuy Spine, Inc. · Dec 2007
MANTIS SPINAL SYSTEM
K073151 · Stryker Corp. · Dec 2007
MERCURY SPINAL SYSTEM
K071914 · Spinal Elements, Inc. · Oct 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · Medtronic Sofamor Danek · Sep 2007
EXPEDIUM SPINE SYSTEM
K070387 · Depuy Spine, Inc. · Sep 2007