Cleared Traditional

K012254 - VBR

K012254 is an FDA 510(k) clearance for VBR, manufactured by Osteotech, 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.

K012254 · Osteotech, Inc. · Orthopedic device
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Oct 2001
Decision
90d
Days
Class 2
Risk

K012254 is an FDA 510(k) clearance for the VBR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on October 16, 2001 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K012254

510(k) Number K012254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date October 16, 2001
Days to Decision 90 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
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 244
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K012254.
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
K010989 · Interpore Cross Intl. · Nov 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · Depuyacromed · Nov 2001
LIFT VB SPINAL SYSTEM
K010930 · Medtronic Sofamor Danek, Inc. · Oct 2001
GEO STRUCTURE
K010530 · Interpore Cross Intl. · Aug 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · Depuyacromed · May 2001