# K210533: Inset Reverse Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Innovations, Inc.
- Decided: Aug 20, 2021 after 177 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: 14 generations back to K911686 (1991). 81 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K113069: Comprehensive Reverse Shoulder Humeral Tray, Biomet Manufacturing Corp (2012) Summary page 4.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 4.
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere, Biomet Manufacturing Corp (2013) Summary page 4.
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Biomet Manufacturing Corp (2018) Summary page 5.
- K181611: Comprehensive Reverse Shoulder System, Biomet Manufacturing Corp (2018) Summary page 5.

## Most influential descendants
- K252221: Inset Reverse Total Shoulder System (2025), 1 descendant of its own
- K254128: InSet Reverse Total Shoulder System (2026), 0 descendants of its own
- K252516: N22 EZ Glenosphere (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 cuffwith 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 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.

Source page: https://510kreport.com/device/K210533
Methodology: https://510kreport.com/methodology