# K013044: Synthes 3.9 MM Pelvic Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 3, 2001 after 84 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
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K122538: Acumed Pelvic Bone Plate System (2012), 4 descendants of its own
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

## Indications for use
The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis as well as for periacetabular osteotomies.

Source page: https://510kreport.com/device/K013044
Methodology: https://510kreport.com/methodology