# K121672: Aft Proximal Humerus Fracture Plate

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Options, Inc.
- Decided: Oct 1, 2012 after 117 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: 2 generations back to K961413 (1996). 6 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K042695: NCB Plating System, Zimmer GmbH (2004) Summary page 1.

## Most influential descendants
- K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul (2014), 16 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own

## Indications for use
The AFTm Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K121672
Methodology: https://510kreport.com/methodology