Cleared Special

K111525 - PERIMETER INTERBODY FUSION DEVICE

K111525 is the FDA 510(k) clearance for PERIMETER INTERBODY FUSION DEVICE by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 84-day FDA review.

K111525 · Medtronic Sofamor Danek · Orthopedic device
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Aug 2011
Decision
84d
Days
Class 2
Risk

K111525 is an FDA 510(k) clearance for the PERIMETER INTERBODY FUSION DEVICE. 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 Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 24, 2011 after a review of 84 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K111525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date August 24, 2011
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K111525.
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
K110783 · L & K Biomed Co., Ltd. · Oct 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · Spineology, Inc. · Sep 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
CAPSTONE R SPINAL SYSTEM
K103731 · Medtronic Sofamor Danek · Jul 2011
PLATEAU SPACER SYSTEM
K111569 · Life Spine · Jul 2011