Cleared Special

K112496 - PIONEER CROSSFUSE II IBF/VBR SYSTEM

K112496 is an FDA 510(k) clearance for PIONEER CROSSFUSE II IBF/VBR SYSTEM, manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 30-day FDA review.

K112496 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Sep 2011
Decision
30d
Days
Class 2
Risk

K112496 is an FDA 510(k) clearance for the PIONEER CROSSFUSE II IBF/VBR SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on September 28, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Pioneer Surgical Technology, Inc. devices

FDA 510(k) Submission Details - K112496

510(k) Number K112496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date September 28, 2011
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 864
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K112496.
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K112014 · Biomet Spine · Oct 2011
CONCORDE BULLET SPINAL SYSTEM
K110694 · Johnson & Johnson · Oct 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553 · Spinefrontier, Inc. · Sep 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · Spineology, Inc. · Sep 2011
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K110659 · Medical Concepts, Inc. · Sep 2011
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111166 · Spineworks, LLC · Sep 2011