Cleared Traditional

K062151 - BOX PEEK VBR SYSTEM

K062151 is the FDA 510(k) clearance for BOX PEEK VBR SYSTEM by Innovasis, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K062151 · Innovasis, Inc. · Orthopedic device
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Dec 2006
Decision
148d
Days
Class 2
Risk

K062151 is an FDA 510(k) clearance for the BOX PEEK VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 148 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 Innovasis, Inc. devices

Submission Details

510(k) Number K062151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date December 22, 2006
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
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 153
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K062151.
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007
ALEUTIAN SPACER SYSTEM
K063399 · K2m, Inc. · Feb 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · Ortho Development Corp. · Jan 2007
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · Ebi, L.P. · Oct 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006