# K180089: Medacta Shoulder System Short Humeral Diaphysis

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 5, 2018 after 83 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). 108 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 5.
- K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System, Tornier S.A.S. (2014) Summary page 5.
- K170910: Medacta Anatomic Shoulder Prosthesis, Medacta International S.A. (2017) Summary page 5.

## Most influential descendants
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K261016: MSS - Humeral reverse liners extension (2026), 0 descendants of its own
- K203755: Shoulder System - TiNbN Coating (2021), 0 descendants of its own

## Indications for use
Reverse Shoulder Prosthesis The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient 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. Short Humeral Diaphysis The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy. 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. Anatomical The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. Short Humeral Diaphysis The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application.

Source page: https://510kreport.com/device/K180089
Methodology: https://510kreport.com/methodology