Cleared Traditional

K113561 - TM ARDIS INTERBODY SYSTEM TM ARDIS INTE...

K113561 is an FDA 510(k) clearance for TM ARDIS INTERBODY SYSTEM TM ARDIS INTE..., manufactured by Zimmer Trabecular Metal Technology. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K113561 · Zimmer Trabecular Metal Technology · Orthopedic device
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May 2012
Decision
180d
Days
Class 2
Risk

K113561 is an FDA 510(k) clearance for the TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION. 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 (Parsippany, US). The FDA issued a Cleared decision on May 29, 2012 after a review of 180 days - an extended review cycle.

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 devices

FDA 510(k) Submission Details - K113561

510(k) Number K113561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date May 29, 2012
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K113561.
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · Medos International SARL · Jul 2012
NUVASIVE COROENT TITANIUM SYSTEM
K120918 · Nuvasive, Inc. · Jun 2012
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
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063 · L & K Biomed Co., Ltd. · Apr 2012