# K171058: Medacta Shoulder System: Threaded Glenoid Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Dec 13, 2017 after 247 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). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132285: Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2013) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.

## 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 and 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/K171058
Methodology: https://510kreport.com/methodology