# K180541: DePuy Synthes 2.0 mm Quick Insertion Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Nov 21, 2018 after 265 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: 11 generations back to K962616 (1996). 93 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142658: Biomet Headless Compression and Twist-off Screws, Biomet Manufacturing Corp (2014) Summary page 4.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.

## Most influential descendants
- K192745: DePuy Synthes Trauma Screws (2019), 5 descendants of its own
- K211783: TriMed Threaded Intramedullary Nail System (2021), 2 descendants of its own
- K230749: TriMed Threaded Intramedullary Nail System (2023), 1 descendant of its own
- K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (2022), 1 descendant of its own
- K220319: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System (2022), 1 descendant of its own

## Indications for use
The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Source page: https://510kreport.com/device/K180541
Methodology: https://510kreport.com/methodology