Cleared Traditional

K093127 - TRABECULAR METAL (TM) VERTEBRAL BODY RE...

K093127 is an FDA 510(k) clearance for TRABECULAR METAL (TM) VERTEBRAL BODY RE..., 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 153-day FDA review.

K093127 · Zimmer Trabecular Metal Technology · Orthopedic device
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Mar 2010
Decision
153d
Days
Class 2
Risk

K093127 is an FDA 510(k) clearance for the TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET. 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 March 4, 2010 after a review of 153 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 - K093127

510(k) Number K093127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date March 04, 2010
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 K093127.
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
STAXX XD SYSTEM
K101288 · Spine Wave, Inc. · Sep 2010
AESCULAP HYDROLIFT VBR SYSTEM
K083186 · Aesculap Implant System, Inc. · Mar 2010
C-THRU SPINAL SYSTEM
K092336 · Ebi, L.P. · Oct 2009
ADDPLUS
K090841 · Ulrich GmbH & Co. KG · Oct 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946 · Stryker Spine · Sep 2009