Cleared Special

K120434 - POWER ADAPTOR INSTRUMENT ACCESSORY

K120434 is the FDA 510(k) clearance for POWER ADAPTOR INSTRUMENT ACCESSORY by Stryker Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 24-day FDA review.

K120434 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
24d
Days
Class 2
Risk

K120434 is an FDA 510(k) clearance for the POWER ADAPTOR INSTRUMENT ACCESSORY. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 8, 2012 after a review of 24 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 Stryker Corp. devices

Submission Details

510(k) Number K120434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date March 08, 2012
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K120434.
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012
TIGER SPINE SYSTEM
K113058 · Corelink, LLC · Mar 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · Orthofix, Inc. · Feb 2012
FOCUS SPINAL SYSTEM
K120140 · L & K Biomed Co., Ltd. · Feb 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · Medtronic Sofamor Danek · Feb 2012