# K193175: Lateralized Glenosphere

- Pathway: 510(k) (Traditional)
- Applicant: Medacta Inernational SA
- Decided: Aug 11, 2020 after 267 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: 11 generations back to K911686 (1991). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 4.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 4.
- K112144: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis, Tornier (2012) Summary page 6.

## Most influential descendants
- K203755: Shoulder System - TiNbN Coating (2021), 0 descendants of its own

## Indications for use
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Source page: https://510kreport.com/device/K193175
Methodology: https://510kreport.com/methodology