# K063033: Modification to Titanium Shoulder Plate Implant

- Pathway: 510(k) (Special)
- Applicant: Orthopedic Sciences, Inc.
- Decided: Nov 1, 2006 after 29 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: 5 generations back to K850886 (1985). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040850: Tsy Shoulder Plate Implant, Orthopedic Sciences, Inc. (2004) Summary page 1.

## Indications for use
The Titanium-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/K063033
Methodology: https://510kreport.com/methodology