Cleared Traditional

K092774 - ATLAS INTERVERTEBRAL BODY CAGE

K092774 is an FDA 510(k) clearance for ATLAS INTERVERTEBRAL BODY CAGE, manufactured by Spinal Edge, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K092774 · Spinal Edge, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
146d
Days
Class 2
Risk

K092774 is an FDA 510(k) clearance for the ATLAS INTERVERTEBRAL BODY CAGE. 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 Spinal Edge, LLC (Avon, US). The FDA issued a Cleared decision on February 2, 2010 after a review of 146 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 Spinal Edge, LLC devices

FDA 510(k) Submission Details - K092774

510(k) Number K092774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date February 02, 2010
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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 687
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K092774.
CRESCENT SPINAL SYSTEM
K094025 · Medtronic Sofamor Danek · Apr 2010
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX
K093864 · Stryker Corp. · Mar 2010
ESL SPINAL SYSTEM
K092574 · Ebi, L.P. · Feb 2010
VALEO SPACER SYSTEM
K091278 · Amedica Corp. · Jan 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K092162 · Solco Biomedical Co., Ltd. · Jan 2010
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · Globus Medical, Inc. · Dec 2009