Cleared Traditional

K111301 - INSTINCT JAVA SYSTEM

K111301 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 109-day FDA review.

K111301 · Zimmer Spine · Orthopedic device
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Aug 2011
Decision
109d
Days
Class 2
Risk

K111301 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 August 26, 2011 after a review of 109 days - within the typical 510(k) review window.

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 - K111301

510(k) Number K111301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2011
Decision Date August 26, 2011
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 K111301.
CD HORIZON SPINAL SYSTEM
K111510 · Medtronic Sofamor Danek, Inc. · Sep 2011
PILOT SPINAL SYSTEM
K111729 · Life Spine, Inc. · Sep 2011
TSRH SPINAL SYSTEMS
K111942 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
STREAMLINE TL SPINAL SYSTEM
K111502 · Pioneer Surgical Technology, Inc. · Aug 2011
REVOLVE ADDITIONAL IMPLANTS
K111449 · Globus Medical, Inc. · Aug 2011
REVERE CROSSTOP
K111479 · Globus Medical, Inc. · Aug 2011