Cleared Traditional

K200606 - O-Genesis Graft Delivery System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200606 · Orthofix, Inc. · General & Plastic Surgery device

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May 2020

Decision

53d

Days

Class 2

Risk

K200606 is an FDA 510(k) clearance for the O-Genesis Graft Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on May 1, 2020 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5860 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthofix, Inc. devices

Submission Details

510(k) Number	K200606 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 09, 2020
Decision Date	May 01, 2020
Days to Decision	53 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

61d faster than avg

Panel avg: 114d · This submission: 53d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FMF Syringe, Piston
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.5860

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 General & Plastic Surgery devices follow this clearance model.