Cleared Traditional

K172199 - ELEVATE Spinal System

K172199 is the FDA 510(k) clearance for ELEVATE Spinal System by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K172199 · Medtronic Sofamor Danek · Orthopedic device
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Sep 2017
Decision
60d
Days
Class 2
Risk

K172199 is an FDA 510(k) clearance for the ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CR.... 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 September 19, 2017 after a review of 60 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 devices

Submission Details

510(k) Number K172199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date September 19, 2017
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K172199.
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
K171689 · Medtronic Sofamor Danek USA, Inc. · Oct 2017
NuVasive TLX Interbody System
K171633 · Nu Vasive, Incorporated · Sep 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · Medtronic Sofamor Danek USA, Inc. · Sep 2017
Duo Lumbar Interbody Fusion Device
K171660 · Spineology, Inc. · Aug 2017
The TiBow Expandable Spacer System
K170919 · Life Spine, Inc. · Aug 2017
Rampart L Lumbar Interbody Fusion Device
K171724 · Spineology, Inc. · Jul 2017