# K191711: ORTHOLOC™ SPS Shoulder Plating System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jul 17, 2019 after 21 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 K100146 (2010). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181587: ORTHOLOC SPS Shoulder Plating System, Tornier, Inc. (2018) Summary page 4.

## Indications for use
The ORTHOLOC™ SPS 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/K191711
Methodology: https://510kreport.com/methodology