Cleared Special

K071860 - MODIFICATION TO: VIPER SPINE SYSTEM

K071860 is the FDA 510(k) clearance for MODIFICATION TO: VIPER SPINE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 27-day FDA review.

K071860 · Depuy Spine, Inc. · Orthopedic device
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Aug 2007
Decision
27d
Days
Class 2
Risk

K071860 is an FDA 510(k) clearance for the MODIFICATION TO: VIPER SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on August 1, 2007 after a review of 27 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K071860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date August 01, 2007
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K071860.
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · Medtronic Sofamor Danek USA, Inc. · Sep 2007
STRYKER SPINE XIA III SPINAL SYSTEM
K071373 · Stryker Spine · Aug 2007
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
K071380 · Alphatec Spine, Inc. · Aug 2007
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
K070631 · Stryker Spine · Jul 2007
EXPEDIUM SPINE SYSTEM
K063772 · Depuy Spine, Inc. · Jul 2007
QUANTUM SPINAL SYSTEM
K070973 · Pioneer Surgical Technology · Jul 2007