# K203755: Shoulder System - TiNbN Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 2, 2021 after 69 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). 234 ancestors in all.
No later device cites it as a predicate yet.
1 of 234 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193175: Lateralized Glenosphere, Medacta Inernational SA (2020) Summary page 5.
- K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 5.
- K170910: Medacta Anatomic Shoulder Prosthesis, Medacta International S.A. (2017) Summary page 5.
- K202684: GMK Total Knee System - TiNbN Coating, Medacta International S.A. (2020) Summary page 5.
- K180089: Medacta Shoulder System Short Humeral Diaphysis, Medacta International S.A. (2018) Summary page 6.

## Indications for use
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. The humeral stems are intended for cemented or cementless use. 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. The humeral short stem is intended for cementless 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 deficient rotator cuff 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. The humeral stems are intended for cemented or cementless use. The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff 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. The humeral short stem is intended for cementless use.

Source page: https://510kreport.com/device/K203755
Methodology: https://510kreport.com/methodology