Cleared Special

K113447 - RISE SPACER

K113447 is the FDA 510(k) clearance for RISE SPACER by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 66-day FDA review.

K113447 · Globus Medical, Inc. · Orthopedic device
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Jan 2012
Decision
66d
Days
Class 2
Risk

K113447 is an FDA 510(k) clearance for the RISE SPACER. 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 Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 66 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K113447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date January 26, 2012
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 610
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K113447.
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293 · Spineology, Inc. · Feb 2012
MECTALIF TRANSFORAMINAL
K120024 · Medacta International S.A. · Feb 2012
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE
K113030 · Spineology, Inc. · Jan 2012
ALEUTIAN SYSTEM
K113138 · K2m, Inc. · Jan 2012
CLYDESDALE(R) SPINAL SYSTEM
K113528 · Medtronic Sofamor Danek USA, Inc. · Dec 2011
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc. · Nov 2011