Cleared Traditional

K062666 - VUSION TS

K062666 is the FDA 510(k) clearance for VUSION TS by Ortho Development Corp.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K062666 · Ortho Development Corp. · Orthopedic device
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Jan 2007
Decision
140d
Days
Class 2
Risk

K062666 is an FDA 510(k) clearance for the VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 140 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 Ortho Development Corp. devices

Submission Details

510(k) Number K062666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2006
Decision Date January 25, 2007
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K062666.
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007
ALEUTIAN SPACER SYSTEM
K063399 · K2m, Inc. · Feb 2007
BOX PEEK VBR SYSTEM
K062151 · Innovasis, Inc. · Dec 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006