Cleared Traditional

K123552 - INSTINCT JAVA SYSTEM

K123552 is an FDA 510(k) clearance for INSTINCT JAVA SYSTEM, manufactured by Zimmer Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K123552 · Zimmer Spine · Orthopedic device
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Apr 2013
Decision
151d
Days
Class 2
Risk

K123552 is an FDA 510(k) clearance for the INSTINCT JAVA SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Zimmer Spine (Minneapolis, US). The FDA issued a Cleared decision on April 19, 2013 after a review of 151 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 Zimmer Spine devices

FDA 510(k) Submission Details - K123552

510(k) Number K123552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date April 19, 2013
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 733
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K123552.
STREAMLINE TL SPINAL SYSTEM
K131100 · Pioneer Surgical Technology, Inc. · Jun 2013
EXPEDIUM SPINE SYSTEM
K130877 · Medos International SARL · Jun 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · Alphatec Spine, Inc. · May 2013
S4 SPINAL SYSTEM
K130291 · Aesculap Implant System, Inc. · Apr 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286 · Pioneer Surgical Technology, Inc. · Apr 2013