Cleared Traditional

K122211 - SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS

K122211 is an FDA 510(k) clearance for SYNTHES NAVIGABLE PEDICLE PREPARATION I..., manufactured by Synthes Spine. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K122211 · Synthes Spine · Neurology device
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Dec 2012
Decision
145d
Days
Class 2
Risk

K122211 is an FDA 510(k) clearance for the SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on December 17, 2012 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes Spine devices

FDA 510(k) Submission Details - K122211

510(k) Number K122211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date December 17, 2012
Days to Decision 145 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 148d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 349
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K122211.
CRANIAL MAP NEURO
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K130874 · Stryker Corporate · Sep 2013
QUADCUT
K130608 · Medtronic Navigation, Inc. · Aug 2013
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc. · Sep 2012
MICROTARGETING XL STAR DRIVE SYSTEM
K121950 · FHC, Inc. · Jul 2012
RENAISSANCE
K120812 · Mazor Robotics , Ltd. · Jul 2012