Cleared Special

K133207 - STAXX(R) SYSTEM

K133207 is an FDA 510(k) clearance for STAXX SYSTEM, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 49-day FDA review.

K133207 · Spine Wave, Inc. · Orthopedic device
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Dec 2013
Decision
49d
Days
Class 2
Risk

K133207 is an FDA 510(k) clearance for the STAXX(R) SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spine Wave, Inc. devices

FDA 510(k) Submission Details - K133207

510(k) Number K133207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date December 06, 2013
Days to Decision 49 days
Submission Type Special
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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K133207.
AIS MODULIFT VBR SYSTEM
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K131888 · Medtronic Sofamor Danek, Inc. · Sep 2013
ENDURAMESH
K122622 · Lucero Medical, LLC · Sep 2012
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K121889 · Spine Wave, Inc. · Aug 2012