Cleared Traditional

K132559 - MONUMENT SPACERS

K132559 is the FDA 510(k) clearance for MONUMENT SPACERS by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K132559 · Globus Medical, Inc. · Orthopedic device
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Dec 2013
Decision
137d
Days
Class 2
Risk

K132559 is an FDA 510(k) clearance for the MONUMENT SPACERS. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 30, 2013 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K132559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2013
Decision Date December 30, 2013
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K132559.
CHESAPEAKE SPINAL SYSTEM
K133494 · K2m, Inc. · Jun 2014
AERO-AL LUMBAR CAGE SYSTEM
K133328 · Stryker Corporation · May 2014
LATERAL SYNFIX
K131276 · Synthes USA Products, LLC · Jan 2014
COROENT SINGLE TAB SYSTEM
K131723 · Nuvasive, Inc. · Sep 2013
MECTALIF ANTERIOR
K124034 · Medacta International · May 2013
BRIGADE STANDALONE SYSTEM
K123045 · Nuvasive, Inc. · Apr 2013