# K262173: N22 Offset Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Sep 8, 2026 after 74 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: 17 generations back to K911686 (1991). 187 ancestors in all.
No later device cites it as a predicate yet.
1 of 188 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241817: InSet Total Shoulder System, Shoulder Innovations, Inc. (2025) Summary page 5.

## 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. N22 Offset Humeral Head made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloys. A Cobalt Alloy humeral head is the recommended component for anatomic shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy.

Source page: https://510kreport.com/device/K262173
Methodology: https://510kreport.com/methodology