Cleared Special

K121020 - VIPER SYSTEM

K121020 is the FDA 510(k) clearance for VIPER SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K121020 · Depuy Spine, Inc. · Orthopedic device
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May 2012
Decision
29d
Days
Class 2
Risk

K121020 is an FDA 510(k) clearance for the VIPER 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 May 3, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 K121020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date May 03, 2012
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 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 K121020.
XIA 4.5 SPINAL SYSTEM
K121342 · Stryker Corp. · Jun 2012
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM
K111136 · Depuy Spine, Inc. · Jun 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · Stryker Corp. · Mar 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · Orthofix, Inc. · Feb 2012