Cleared Special

NUVASIVE SPHERX SYSTEM (K082332) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082332 · Nuvasive, Inc. · Orthopedic device
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Oct 2008
Decision
57d
Days
Class 2
Risk

K082332 is an FDA 510(k) clearance for the NUVASIVE SPHERX SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 57 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K082332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date October 10, 2008
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 403
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K082332.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K091974 · Medtronic Sofamor Danek USA, Inc. · Sep 2009
REVERE 6.35 STABILIZATION SYSTEM
K091782 · Globus Medical, Inc. · Aug 2009
REVOLVE STABILIZATION SYSTEM
K083416 · Globus Medical, Inc. · Jan 2009
REVERE UNIPLANAR SCREWS
K081195 · Globus Medical, Inc. · May 2008
H-LINK INTEGRATED ROD
K073517 · Globus Medical, Inc. · Jan 2008
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007