Cleared Special

K170539 - Avitus Bone Harvester with Filter Inser...

K170539 is an FDA 510(k) clearance for Avitus Bone Harvester with Filter Inser..., manufactured by Avitus Orthopaedics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 25-day FDA review.

K170539 · Avitus Orthopaedics, Inc. · Gastroenterology & Urology device
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Mar 2017
Decision
25d
Days
Class 2
Risk

K170539 is an FDA 510(k) clearance for the Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, .... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Avitus Orthopaedics, Inc. (Farmington, US). The FDA issued a Cleared decision on March 20, 2017 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avitus Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K170539

510(k) Number K170539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2017
Decision Date March 20, 2017
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 184
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K170539.
Bard Mission Disposable Core Biopsy Instrument
K171953 · Bard Peripheral Vascular, Inc. · Sep 2017
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K171531 · Care Fusion · Sep 2017
Brevera Biopsy System with Corlumina Imaging Technology
K163052 · Hologic, Inc. · Mar 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · Cook Incorporated · Feb 2017
EnCor MRI Introducer Set, EnCor Probe Introducer
K161805 · Senorx, Inc. · Jul 2016
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016