# K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Avanti Orthopaedics, Inc.
- Decided: Nov 23, 2022 after 57 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 142 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 5.
- K180541: DePuy Synthes 2.0 mm Quick Insertion Screws, Synthes USA Products, LLC (2018) Summary page 5.
- K162825: CAPTIVATE™ Compression Screws, Globus Medical, Inc. (2017) Summary page 5.

## Most influential descendants
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own

## Indications for use
The Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Source page: https://510kreport.com/device/K222967
Methodology: https://510kreport.com/methodology