Cleared Traditional

SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM (K072116) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072116 · Neurospine Innovations and Solutions · Orthopedic device
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Mar 2008
Decision
232d
Days
Class 2
Risk

K072116 is an FDA 510(k) clearance for the SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Neurospine Innovations and Solutions (Apple Valley, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 232 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurospine Innovations and Solutions devices

Submission Details

510(k) Number K072116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date March 20, 2008
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 438
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K072116.
TSRH SPINAL SYSTEM
K081080 · Medtronic Sofamor Danek · Nov 2008
CD HORIZON SPINAL SYSTEM
K082236 · Medtronic Sofamor Danek · Oct 2008
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
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · Medtronic Sofamor Danek · Sep 2007