# K241817: InSet Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Feb 11, 2025 after 232 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: 16 generations back to K911686 (1991). 186 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 188 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192365: Shoulder Innovations Total Shoulder System, Shoulder Innovations, Inc. (2019) Summary page 5.
- K212737: INHANCE™ Reverse Shoulder System, Depuy Ireland UC (2022) Summary page 5.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 5.

## Most influential descendants
- K262173: N22 Offset Humeral Head (2026), 0 descendants of its own

## Indications for use
The Shoulder Innovation’s InSet Total Shoulder System, when used with the Inset Stem, 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. Fractures of the humeral head 3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 4. Avascular necrosis of the humeral head 5. Revision where other devices or treatments have failed. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The InSet 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/K241817
Methodology: https://510kreport.com/methodology