# Avanti Orthopaedics, Inc.

- Location (FDA's records): Wilmington, DE
- FDA decisions: 4 (2019–2026): 4 510(k) clearances
- Names in FDA's records: Avanti Orthopaedics, Inc. (3); Avanti Orthopaedics, LLC (1)
- Product codes: HRS (3), HWC (1)
- 510(k) review time since 2016: median 55 days, against 88 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 16 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Medartis AG: 2 (https://510kreport.com/company/medartis)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- Newclip Technics: 1 (https://510kreport.com/company/newclip-technics)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Syntec Scientific Corp.: 1 (https://510kreport.com/company/syntec-scientific)

## Its most-cited devices
- K211592: Avanti Orthopaedics Ulnar Shortening System (2021), cited by 1
- K191118: Avanti Distal Radius and Forearm System (2019), cited by 1
- K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (2022), cited by 1

## Recent decisions
- K261145: Avanti Distal Elbow ORIF System (May 9, 2026)
- K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (Nov 23, 2022)
- K211592: Avanti Orthopaedics Ulnar Shortening System (Jul 16, 2021)
- K191118: Avanti Distal Radius and Forearm System (Dec 13, 2019)

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