Cleared Traditional

K071031 - VU E*POD VERTEBRAL BODY REPLACEMENT

K071031 is an FDA 510(k) clearance for VU E*POD VERTEBRAL BODY REPLACEMENT, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K071031 · Theken Spine, LLC · Orthopedic device
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Jul 2007
Decision
110d
Days
Class 2
Risk

K071031 is an FDA 510(k) clearance for the VU E*POD VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 - K071031

510(k) Number K071031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2007
Decision Date July 30, 2007
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 189
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K071031.
RELIANCE VBS SYSTEM
K063637 · Reliance Medical Systems, LLC · Sep 2007
LDR SPINE ROI-T SYSTEM
K072132 · Ldr Spine USA · Aug 2007
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · Theken Spine, LLC · Jun 2007
THEKEN VU MESH VBR SYSTEM
K070381 · Theken Spine, LLC · Apr 2007
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007