Cleared Special

K121116 - PLATEAU SPACER SYSTEM

K121116 is the FDA 510(k) clearance for PLATEAU SPACER SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 26-day FDA review.

K121116 · Life Spine · Orthopedic device
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May 2012
Decision
26d
Days
Class 2
Risk

K121116 is an FDA 510(k) clearance for the PLATEAU SPACER 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 Life Spine (Hoffman Est, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 26 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.

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Submission Details

510(k) Number K121116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date May 08, 2012
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K121116.
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · Nuvasive, Inc. · Jun 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · Spineology, Inc. · Jun 2012
LUCENT OR LUCENT MAGNUM
K110632 · Spinal Elements, Inc. · May 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063 · L & K Biomed Co., Ltd. · Apr 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · Medtronic Sofamor Danek USA, Inc. · Apr 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293 · Spineology, Inc. · Feb 2012