Cleared Traditional

K073439 - TRANSITION STABILIZATION SYSTEM (FDA 510(k) Clearance)

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

K073439 · Globus Medical, Inc. · Orthopedic device
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Feb 2009
Decision
441d
Days
Class 2
Risk

K073439 is an FDA 510(k) clearance for the TRANSITION STABILIZATION SYSTEM. Classified as Posterior Metal/polymer Spinal System, Fusion (product code NQP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K073439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 07, 2007
Decision Date February 20, 2009
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQP Posterior Metal/polymer Spinal System, Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine.
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.