Cleared Special

Avitus(r) Bone Harvester (K210631) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210631 · Avitus Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
28d
Days
Class 2
Risk

K210631 is an FDA 510(k) clearance for the Avitus(r) Bone Harvester. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Avitus Orthopaedics, Inc. (Shelton, US). The FDA issued a Cleared decision on March 31, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 876.1075 - the FDA orthopedic device regulatory 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

Submission Details

510(k) Number K210631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2021
Decision Date March 31, 2021
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Orthopedic devices follow this clearance model.

Regulatory Consultant

Keystone Regulatory Services, LLC
William McLain

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 105
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K210631.
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Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
K203397 · Biopsybell S.R.L. · Jan 2021