Cleared Special

K133286 - MIDLINE (TM)

K133286 is the FDA 510(k) clearance for MIDLINE (TM) by Centinel Spine, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Special 510(k) pathway after a 76-day FDA review.

K133286 · Centinel Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
76d
Days
Class 2
Risk

K133286 is an FDA 510(k) clearance for the MIDLINE (TM). Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Centinel Spine, Inc. (West Chester, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 76 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 Centinel Spine, Inc. devices

Submission Details

510(k) Number K133286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date January 09, 2014
Days to Decision 76 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

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 K133286.
COROENT XL-F SYSTEM
K140479 · Nu Vasive, Incorporated · Jul 2014
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
MONUMENT SPACERS
K132559 · Globus Medical, Inc. · Dec 2013
COROENT SINGLE TAB SYSTEM
K131723 · Nuvasive, Inc. · Sep 2013