# K252221: Inset Reverse Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Sep 26, 2025 after 72 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). 130 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 132 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 5.
- K210533: Inset Reverse Total Shoulder System, Shoulder Innovations, Inc. (2021) Summary page 5.

## Most influential descendants
- K254128: InSet Reverse Total Shoulder System (2026), 0 descendants of its own

## 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 arthropathy 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, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The System can be used to treat fractures of the humeral head, and revision of other devices if sufficient bone stock remains. 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.

Source page: https://510kreport.com/device/K252221
Methodology: https://510kreport.com/methodology