# K230053: SimpliFix Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Stabiliz Orthopaedics, Inc.
- Decided: Apr 19, 2023 after 103 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: 10 generations back to K962616 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 4.

## Indications for use
The SimpliFix Hip System is intended for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.

Source page: https://510kreport.com/device/K230053
Methodology: https://510kreport.com/methodology