Cleared Traditional

K070381 - THEKEN VU MESH VBR SYSTEM

K070381 is an FDA 510(k) clearance for THEKEN VU MESH VBR SYSTEM, 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 76-day FDA review.

K070381 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
76d
Days
Class 2
Risk

K070381 is an FDA 510(k) clearance for the THEKEN VU MESH VBR SYSTEM. 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 April 25, 2007 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theken Spine, LLC devices

FDA 510(k) Submission Details - K070381

510(k) Number K070381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date April 25, 2007
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 275
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K070381.
SMALL STATURE SPACERS
K063393 · Biomet Spine · Jun 2007
MODIFICATION TO: INTERPLATE VBR SYSTEM
K071372 · Rsb Spine, LLC · Jun 2007
VISTA -S DEVICE
K070382 · Zimmer Trabecular Metal Technology · May 2007
XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
K070082 · Vertebration,Inc · Apr 2007
INTERPLATE VBR SYSTEM
K070316 · Rsb Spine, LLC · Apr 2007
SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
K070181 · Sintea Biotech, Inc. · Apr 2007