# K254128: InSet Reverse Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Apr 13, 2026 after 112 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: 16 generations back to K911686 (1991). 192 ancestors in all.
No later device cites it as a predicate yet.
1 of 193 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252221: Inset Reverse Total Shoulder System, Shoulder Innovations, Inc. (2025) Summary page 5.
- K212737: INHANCE™ Reverse Shoulder System, Depuy Ireland UC (2022) Summary page 5.

## Indications for use
Reverse Total Shoulder: 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 the fractures of the humeral head, fractures of the proximal humerus where other methods of treatment are deemed inadequate (with Standard Humeral Stems), 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/K254128
Methodology: https://510kreport.com/methodology