Cleared Special

REVERE SACRAL PLATES (K103072) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103072 · Globus Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2011
Decision
150d
Days
Class 2
Risk

K103072 is an FDA 510(k) clearance for the REVERE SACRAL PLATES. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 17, 2011 after a review of 150 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Standard predicate reliance. 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 K103072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date March 17, 2011
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 401
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K103072.
REVOLVE ADDITIONAL IMPLANTS
K111449 · Globus Medical, Inc. · Aug 2011
REVERE CROSSTOP
K111479 · Globus Medical, Inc. · Aug 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011
CD HORIZON SPINAL SYSTEM
K102555 · Medtronic Sofamor Danek USA, Inc. · Nov 2010
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010