Cleared Traditional

K100634 - SYNTHES MATRIX SYSTEM

K100634 is the FDA 510(k) clearance for SYNTHES MATRIX SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K100634 · Synthes (Usa) · Orthopedic device
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Jul 2010
Decision
118d
Days
Class 2
Risk

K100634 is an FDA 510(k) clearance for the SYNTHES MATRIX SYSTEM. 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 July 1, 2010 after a review of 118 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 K100634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date July 01, 2010
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K100634.
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · Synthes Spine · Aug 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · Blackstone Medical, Inc. · Jul 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · Stryker Spine · Jul 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438 · Ebi, L.P. · Jun 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010
POLARIS SPINAL SYSTEM
K100220 · Ebi, L.P. · May 2010