Cleared Traditional

K032812 - ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT

K032812 is an FDA 510(k) clearance for ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT, manufactured by Orthovita, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K032812 · Orthovita, Inc. · Orthopedic device
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Dec 2003
Decision
90d
Days
Class 2
Risk

K032812 is an FDA 510(k) clearance for the ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on December 8, 2003 after a review of 90 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 Orthovita, Inc. devices

FDA 510(k) Submission Details - K032812

510(k) Number K032812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date December 08, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 162
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K032812.
VERTE-STACK SPINAL SYSTEM
K040167 · Medtronic Sofamor Danek · Feb 2004
TITANIUM MESH SYSTEM
K032371 · Encore Medical, L.P. · Feb 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
NUVASIVE MESH
K032476 · Nuvasive, Inc. · Nov 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · Implex Corp. · Oct 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · Blackstone Medical, Inc. · Oct 2003