Cleared Traditional

K113270 - INSTINCT JAVA SYSTEM

K113270 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 42-day FDA review.

K113270 · Zimmer Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
42d
Days
Class 2
Risk

K113270 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 December 16, 2011 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer Spine devices

FDA 510(k) Submission Details - K113270

510(k) Number K113270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2011
Decision Date December 16, 2011
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 K113270.
FOCUS MIS SYSTEM
K112643 · L & K Biomed Co., Ltd. · Jan 2012
SYNTHES MIRS
K113044 · Synthes Spine · Dec 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · Lanx, Inc. · Dec 2011
S4 SPINAL SYSTEM
K112551 · Aesculap Implant System, Inc. · Nov 2011
CD HORIZON SPINAL SYSTEM
K113174 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
SYNTHES USS
K111358 · Synthes Spine · Nov 2011