Cleared Traditional

K070754 - TRABECULAR METAL VERTEBRAL BODY REPLACE...

K070754 is an FDA 510(k) clearance for TRABECULAR METAL VERTEBRAL BODY REPLACE..., manufactured by Zimmer Trabecular Metal Technology. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K070754 · Zimmer Trabecular Metal Technology · Orthopedic device
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Aug 2007
Decision
165d
Days
Class 2
Risk

K070754 is an FDA 510(k) clearance for the TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Zimmer Trabecular Metal Technology (Parsippany, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 165 days - an extended review 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: 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 Zimmer Trabecular Metal Technology devices

FDA 510(k) Submission Details - K070754

510(k) Number K070754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2007
Decision Date August 31, 2007
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
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 201
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K070754.
ZUMA
K071726 · Seaspine, Inc. · Oct 2007
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007
RELIANCE VBS SYSTEM
K063637 · Reliance Medical Systems, LLC · Sep 2007
LDR SPINE ROI-T SYSTEM
K072132 · Ldr Spine USA · Aug 2007
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · Theken Spine, LLC · Jul 2007