# K143721: PRCT2

- Pathway: 510(k) (Traditional)
- Applicant: Fx Solutions
- Decided: Aug 27, 2015 after 241 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: 7 generations back to K000684 (2000). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 5.
- K110086: Ifs Profile Plates, Screws, and Washers, Internal Fixation Systems, Inc. (2011) Summary page 5.

## Indications for use
PRCT2 is indicated for use in fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Source page: https://510kreport.com/device/K143721
Methodology: https://510kreport.com/methodology