# K133668: Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate, Right, Aft Greater Tuberosity Cannul

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Options, Inc.
- Decided: Mar 3, 2014 after 94 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: 3 generations back to K961413 (1996). 8 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121672: Aft Proximal Humerus Fracture Plate, Shoulder Options, Inc. (2012) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- 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
- K212433: Anthem Fracture System (2021), 7 descendants of its own

## Indications for use
The AFT Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. The AFT Greater Tuberosity 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/K133668
Methodology: https://510kreport.com/methodology