Cleared Traditional

K213196 - MARVEL™ Growing Rods (FDA 510(k) Clearance)

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

K213196 · Globus Medical, Inc. · Orthopedic device
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Dec 2022
Decision
446d
Days
Class 2
Risk

K213196 is an FDA 510(k) clearance for the MARVEL™ Growing Rods. Classified as Growing Rod System (product code PGM), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 19, 2022 after a review of 446 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 K213196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date December 19, 2022
Days to Decision 446 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 122d · This submission: 446d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGM Growing Rod System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.
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.