Cleared Special

K153438 - PERIMETER C (Titanium) Spinal System

K153438 is the FDA 510(k) clearance for PERIMETER C (Titanium) Spinal System by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 96-day FDA review.

K153438 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Mar 2016
Decision
96d
Days
Class 2
Risk

K153438 is an FDA 510(k) clearance for the PERIMETER C (Titanium) Spinal System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on March 2, 2016 after a review of 96 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. 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K153438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2015
Decision Date March 02, 2016
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K153438.
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