Cleared Traditional

K162680 - SOVEREIGN Spinal System

K162680 is the FDA 510(k) clearance for SOVEREIGN Spinal System by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K162680 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Dec 2016
Decision
79d
Days
Class 2
Risk

K162680 is an FDA 510(k) clearance for the SOVEREIGN® Spinal System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 14, 2016 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K162680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date December 14, 2016
Days to Decision 79 days
Submission Type Traditional
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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K162680.
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K170455 · Medacta International S.A. · Mar 2017
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
K162351 · SeaSpine Orthopedics Corporation · Dec 2016
Leva® Anterior Interbody System
K161993 · Spine Wave, Inc. · Nov 2016
ELSA Spacers
K161379 · Globus Medical, Inc. · Sep 2016