Cleared Traditional

Avitus® Precision Autograft Delivery System (K230492) - FDA 510(k) Clearance

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

K230492 · Avitus Orthopaedics, Inc. · General & Plastic Surgery device
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Jun 2023
Decision
123d
Days
Class 2
Risk

K230492 is an FDA 510(k) clearance for the Avitus® Precision Autograft Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Avitus Orthopaedics, Inc. (Shelton, US). The FDA issued a Cleared decision on June 26, 2023 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Avitus Orthopaedics, Inc. devices

Submission Details

510(k) Number K230492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2023
Decision Date June 26, 2023
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 K230492.
A-TAP (previously called Arthrotap)
K231900 · Elcam Medical Acal · Jul 2023
Hypodermic Syringes & Needle
K222925 · Lifelong Meditech Private Limited · Jul 2023
Avitus® DragonWing Large Volume Autograft Delivery System
K231456 · Avitus Orthopaedics, Inc. · Jul 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
K212857 · Jiangsu Zhiyu Medical Instrument Co, Ltd. · May 2023
Sol-Guard Auto-disable Syringe
K220713 · Sol-Millennium Medical, Inc. · May 2023
EpiFinder
K221974 · Omeq Medical , Ltd. · Apr 2023