510(k) Report

FDA applicant

Avitus Orthopaedics, Inc.

Shelton, CT5 decisions2015–20232 recalls

FDA records 5 decisions for Avitus Orthopaedics, Inc. (Shelton, CT) from 2015 to 2023: 5 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Avitus Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2015: 12017: 12021: 12023: 2
2015high 2 (2023) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2015high 2 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Avitus Orthopaedics, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Avitus Orthopaedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KNWInstrument, Biopsy3decisions
  • FMFSyringe, Piston2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 20151cites it
  • K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with…Avitus Orthopaedics, Inc. · 20171cites it
  • K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 20211cites it

What has FDA decided for it lately?

  • K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc. · 2023
  • K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc. · 2023
  • K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021
  • K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with…Avitus Orthopaedics, Inc. · 20171 recall
  • K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 20151 recall

All 5 as Avitus Orthopaedics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K152474Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and…Feb 18, 2019Class II
  • K170539Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and…Feb 18, 2019Class II