# K252516: N22 EZ Glenosphere

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Jan 15, 2026 after 157 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 82 ancestors in all.
No later device cites it as a predicate yet.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210533: Inset Reverse Total Shoulder System, Shoulder Innovations, Inc. (2021) Summary page 5.

## Indications for use
The InSet Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthoplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The InSet Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation. N22 EZ Glenosphere 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 alloy. A Cobalt Alloy Glenosphere is the recommended component for reverse shoulder arthoplasty patients without material sensitivity to the constituents of CoCr alloy.

Source page: https://510kreport.com/device/K252516
Methodology: https://510kreport.com/methodology