# Avitus Orthopaedics, Inc.

- Location (FDA's records): Shelton, CT
- FDA decisions: 5 (2015–2023): 5 510(k) clearances
- Product codes: KNW (3), FMF (2)
- 510(k) review time since 2016: median 44 days, against 132 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spinal Surgical Strategies, LLC: 2 (https://510kreport.com/company/spinal-surgical-strategies)
- Stemcor Systems, Inc.: 1 (https://510kreport.com/company/stemcor-systems)

## Firms that cite its devices most
- Forcyte Medical, LLC: 1 (https://510kreport.com/company/forcyte-medical)

## Its most-cited devices
- K152474: Avitus Bone Harvester (2015), cited by 1
- K170539: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (2017), cited by 1
- K210631: Avitus (r) Bone Harvester (2021), cited by 1

## Recent decisions
- K231456: Avitus® DragonWing Large Volume Autograft Delivery System (Jul 17, 2023)
- K230492: Avitus® Precision Autograft Delivery System (Jun 26, 2023)
- K210631: Avitus (r) Bone Harvester (Mar 31, 2021)
- K170539: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (Mar 20, 2017)
- K152474: Avitus Bone Harvester (Oct 23, 2015)

Source page: https://510kreport.com/company/avitus-orthopaedics