Cleared Traditional

K082406 - EXPANDABLE PEEK-OPTIMA IMPLANT

K082406 is the FDA 510(k) clearance for EXPANDABLE PEEK-OPTIMA IMPLANT by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K082406 · Ebi, L.P. · Orthopedic device
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Jan 2009
Decision
146d
Days
Class 2
Risk

K082406 is an FDA 510(k) clearance for the EXPANDABLE PEEK-OPTIMA IMPLANT. 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 Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on January 14, 2009 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 Ebi, L.P. devices

Submission Details

510(k) Number K082406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2008
Decision Date January 14, 2009
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
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 610
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082406.
ALEUTIAN IBF SYSTEM
K082698 · K2m, Inc. · Apr 2009
AVS TL PEEK SPACERS
K083661 · Stryker Corp. · Feb 2009
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K081888 · Spineart · Feb 2009
CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek · Dec 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · Medtronic Sofamor Danek USA, Inc. · Oct 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · Medtronic Sofamor Danek · Sep 2008