Cleared Traditional

PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES (K100845) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100845 · Zimmer Spine, Inc. · Orthopedic device
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Sep 2010
Decision
180d
Days
Class 2
Risk

K100845 is an FDA 510(k) clearance for the PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES. 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, Inc. (Austin, US). The FDA issued a Cleared decision on September 21, 2010 after a review of 180 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, Inc. devices

Submission Details

510(k) Number K100845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2010
Decision Date September 21, 2010
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 369
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K100845.
REVERE CROSSTOP
K111479 · Globus Medical, Inc. · Aug 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
COCR RODS
K100788 · Globus Medical, Inc. · May 2010
SYNTHES MATRIX MIS RODS
K093668 · Synthes (Usa) · Mar 2010