Cleared Traditional

3D GraftRasp System (K200431) - FDA 510(k) Clearance

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

K200431 · Surgentec · General & Plastic Surgery device
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May 2020
Decision
87d
Days
Class 2
Risk

K200431 is an FDA 510(k) clearance for the 3D GraftRasp System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Surgentec (Boca Raton, US). The FDA issued a Cleared decision on May 18, 2020 after a review of 87 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 Surgentec devices

Submission Details

510(k) Number K200431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2020
Decision Date May 18, 2020
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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.

Regulatory Peers - FMF Syringe, Piston

All 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K200431.
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K200629 · Control Medical Technology · May 2020
O-Genesis Graft Delivery System
K200606 · Orthofix, Inc. · May 2020
Omnifix Low Dead Space Luer Lock Syringe
K193101 · B.Braun Medical, Inc. · Mar 2020
Mixing and Delivery System
K192674 · Bone Solutions, Inc. · Feb 2020