# K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Sep 20, 2022 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031573 (2003). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042377: Synthes Low Profile Reconstruction Plates, Synthes (Usa) (2004) Summary page 4.
- K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 4.

## Most influential descendants
- K260054: I.T.S. PRS Phoenix II (2026), 0 descendants of its own
- K241666: EVOS Pelvic and Acetabular System (2025), 0 descendants of its own

## Indications for use
The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greather than 12 through 21 years of age) where all growth plates within the acetabulum are fused.

Source page: https://510kreport.com/device/K221809
Methodology: https://510kreport.com/methodology