# K163003: Y3 Proximal Femoral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Mar 16, 2017 after 139 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: 6 generations back to K981372 (1998). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate, Zimmer GmbH (2012) Summary page 5.
- K151907: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables, Zimmer, Inc. (2015) Summary page 5.

## Indications for use
The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter or of the proximal femur. It is indicated for the following: * Re-attachment of the greater trochanter following osteotomy in THA * Trochanteric and intertrochanteric fractures * Extended trochanteric osteotomy * Periprosthetic femoral fractures * Comminuted fractures * Mal-unions and non-unions * Fractures in osteopenic bone

Source page: https://510kreport.com/device/K163003
Methodology: https://510kreport.com/methodology