Cleared Traditional

K042600 - STANSION MATRIX

K042600 is an FDA 510(k) clearance for STANSION MATRIX, manufactured by Spineworks, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K042600 · Spineworks, LLC · Orthopedic device
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Feb 2005
Decision
148d
Days
Class 2
Risk

K042600 is an FDA 510(k) clearance for the STANSION MATRIX. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spineworks, LLC (Washington, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Spineworks, LLC devices

FDA 510(k) Submission Details - K042600

510(k) Number K042600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2004
Decision Date February 18, 2005
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 201
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K042600.
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
RABEA SPINAL IMPLANT
K043316 · Signus Medizintechnik GmbH · Feb 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005