# K192365: Shoulder Innovations Total Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Shoulder Innovations, Inc.
- Decided: Nov 29, 2019 after 91 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K800494 (1980). 38 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111596: Total Shoulder System, Shoulder Innovations, LLC (2011) Summary page 4.
- K173824: Humeral Short Stem System, Shoulder Innovations, Inc. (2018) Summary page 4.

## Most influential descendants
- K241817: InSet Total Shoulder System (2025), 1 descendant of its own
- K262173: N22 Offset Humeral Head (2026), 0 descendants of its own

## Indications for use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; 2. avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

Source page: https://510kreport.com/device/K192365
Methodology: https://510kreport.com/methodology