Cleared Traditional

K214010 - Anteralign Spinal System with Titan nan...

K214010 is the FDA 510(k) clearance for Anteralign Spinal System with Titan nan... by Medtronic Sofamor Danek USA. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K214010 · Medtronic Sofamor Danek USA · Orthopedic device
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Apr 2022
Decision
111d
Days
Class 2
Risk

K214010 is an FDA 510(k) clearance for the Anteralign Spinal System with Titan nanoLOCK Surface Technology. 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 USA (Memphis, US). The FDA issued a Cleared decision on April 12, 2022 after a review of 111 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek USA devices

Submission Details

510(k) Number K214010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date April 12, 2022
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K214010.
WaveForm L System, WaveForm TO System, WaveForm TA System
K213420 · SeaSpine Orthopedics Corporation · May 2022
EARP Interbody System
K212477 · Nvision Biomedical Technologies, Inc. · Apr 2022
Ti3Z Lumbar Interbody System
K212811 · Zavation Medical Products, LLC · Apr 2022
Toro-L Interbody Fusion System
K213355 · Integrity Implants, Inc. · Mar 2022
FlareHawk Interbody Fusion System
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X-Pac Expandable Lumbar Cage System
K220655 · Expanding Innovations, Inc. · Mar 2022