# K252699: CoAptix S System

- Pathway: 510(k) (Traditional)
- Applicant: University of Utah, Department of Orthopaedics
- Decided: Apr 10, 2026 after 226 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). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 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.
- K203595: DynaFuse Fixation System, MedShape, Inc. (2022) Summary page 5.

## Indications for use
The CoAptix S System is intended for the fixation of bone fractures, fusions, osteotomies, reconstructions, non-unions, and malunions in adults. The System is indicated for long bones and long bone fragments, pelvic bones (including the sacrum), and the foot.

Source page: https://510kreport.com/device/K252699
Methodology: https://510kreport.com/methodology