Cleared Traditional

K093668 - SYNTHES MATRIX MIS RODS

K093668 is the FDA 510(k) clearance for SYNTHES MATRIX MIS RODS by Synthes (Usa). It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K093668 · Synthes (Usa) · Orthopedic device
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Mar 2010
Decision
102d
Days
Class 2
Risk

K093668 is an FDA 510(k) clearance for the SYNTHES MATRIX MIS RODS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 9, 2010 after a review of 102 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 Synthes (Usa) devices

Submission Details

510(k) Number K093668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date March 09, 2010
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 122d · This submission: 102d
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 659
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K093668.
COCR RODS
K100788 · Globus Medical, Inc. · May 2010
TSRH SPINAL SYSTEM
K091797 · Medtronic Sofamor Danek · Apr 2010
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
K100737 · Stryker Spine · Apr 2010
REVERE STABILIZATION SYSTEM
K093294 · Globus Medical, Inc. · Feb 2010
SYNTHES MATRIX SYSTEM
K092929 · Synthes (Usa) · Dec 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · Medtronic Sofamor Danek USA, Inc. · Dec 2009