Cleared Traditional

CUTTING EDGE SPINE INTERBODY FUSION DEVICE (K102957) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102957 · Cutting Edge Spine, LLC · Orthopedic device
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Apr 2011
Decision
205d
Days
Class 2
Risk

K102957 is an FDA 510(k) clearance for the CUTTING EDGE SPINE INTERBODY FUSION DEVICE. 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 Cutting Edge Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on April 28, 2011 after a review of 205 days - an extended review 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: 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 Cutting Edge Spine, LLC devices

Submission Details

510(k) Number K102957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2010
Decision Date April 28, 2011
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
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 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K102957.
PERIMETER INTERBODY FUSION DEVICE
K111525 · Medtronic Sofamor Danek · Aug 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
CAPSTONE R SPINAL SYSTEM
K103731 · Medtronic Sofamor Danek · Jul 2011
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · Globus Medical, Inc. · Dec 2010
CLYDESDALE SPINAL SYSTEM
K100175 · Medtronic Sofamor Danek · Jun 2010