# K221467: INHANCETM Reverse Glenoid Peripheral Posts

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Aug 31, 2022 after 103 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: 18 generations back to K911686 (1991). 212 ancestors in all.
No later device cites it as a predicate yet.
1 of 213 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212737: INHANCE™ Reverse Shoulder System, Depuy Ireland UC (2022) Summary page 4.
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2021) Summary page 4.

## Indications for use
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. • A severely painful, disabling, arthritic joint • Fractures of the humeral head (with Short Humeral Stems) • Fractures of the humeral head and proximal humerus (with Standard or Long Stems) • Revisions of previously failed shoulder joint replacements Fixation Methods The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Source page: https://510kreport.com/device/K221467
Methodology: https://510kreport.com/methodology