Cleared Traditional

K082712 - THEKEN SPINE VU EPOD AND VU LPOD SYSTEM

K082712 is an FDA 510(k) clearance for THEKEN SPINE VU EPOD AND VU LPOD SYSTEM, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K082712 · Theken Spine, LLC · Orthopedic device
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Jan 2009
Decision
108d
Days
Class 2
Risk

K082712 is an FDA 510(k) clearance for the THEKEN SPINE VU EPOD AND VU LPOD SYSTEM. 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 Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on January 2, 2009 after a review of 108 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 Theken Spine, LLC devices

FDA 510(k) Submission Details - K082712

510(k) Number K082712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date January 02, 2009
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 643
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082712.
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K081888 · Spineart · Feb 2009
LDR SPINE ROI INTERBODY FUSION SYSTEM
K082262 · Ldr Spine USA · Feb 2009
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · Ebi, L.P. · Jan 2009
CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek · Dec 2008
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082310 · Seaspine, Inc. · Nov 2008
SPINAL USA VBR SYSTEM
K081196 · Spinal USA · Oct 2008