Cleared Traditional

K170855 - T-Rex Standalone ALIF (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170855 · Siats, LLC · Orthopedic device
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Sep 2017
Decision
169d
Days
Class 2
Risk

K170855 is an FDA 510(k) clearance for the T-Rex Standalone ALIF. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Siats, LLC (Tulsa, US). The FDA issued a Cleared decision on September 7, 2017 after a review of 169 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.

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Submission Details

510(k) Number K170855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2017
Decision Date September 07, 2017
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 197
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