# K040850: Tsy Shoulder Plate Implant

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Sciences, Inc.
- Decided: Jun 24, 2004 after 85 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: 4 generations back to K850886 (1985). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022139: Hip Tool Implant, Orthopedic Sciences, Inc. (2002) Summary page 1.

## Most influential descendants
- K063033: Modification to Titanium Shoulder Plate Implant (2006), 0 descendants of its own

## Indications for use
The TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

Source page: https://510kreport.com/device/K040850
Methodology: https://510kreport.com/methodology