Cleared Traditional

K120203 - TM-400 DEVICE

K120203 is an FDA 510(k) clearance for TM-400 DEVICE, manufactured by Zimmer Trabecular Metal Technology, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K120203 · Zimmer Trabecular Metal Technology, Inc. · Orthopedic device
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Jun 2012
Decision
144d
Days
Class 2
Risk

K120203 is an FDA 510(k) clearance for the TM-400 DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Zimmer Trabecular Metal Technology, Inc. (Parsippany, US). The FDA issued a Cleared decision on June 15, 2012 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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, Inc. devices

FDA 510(k) Submission Details - K120203

510(k) Number K120203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date June 15, 2012
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 685
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K120203.
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NUVASIVE COROENT TITANIUM SYSTEM
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SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · Spineology, Inc. · Jun 2012
LUCENT OR LUCENT MAGNUM
K110632 · Spinal Elements, Inc. · May 2012
PLATEAU SPACER SYSTEM
K121116 · Life Spine · May 2012