# K211435: PAO Cortical Screw

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Aug 6, 2021 after 88 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). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 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 4.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.
- K111316: Aap Cannulated Screws, Aap Implantate AG (2011) Summary page 4.

## Indications for use
The PAO cortical screws are intended to refixate the acetabular fragment to the ilium, after Periacetabular osteotomy.

Source page: https://510kreport.com/device/K211435
Methodology: https://510kreport.com/methodology