# K170452: Medacta Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 5, 2017 after 232 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: 10 generations back to K911686 (1991). 63 ancestors in all.
12 later devices descend from it; 8 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K071379: Delta Xtend Reverse Shoulder Modular Stem, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K072804: Comprehensive RS Shoulder System, Biomet Manufacturing Corp (2007) Summary page 4.
- K083439: Synthes Epoca Shoulder Prosthesis System, Synthes (Usa) (2009) Summary page 4.
- K112144: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis, Tornier (2012) Summary page 4.

## Most influential descendants
- K191433: AGILON® XO Shoulder Replacement System (2020), 3 descendants of its own
- K180089: Medacta Shoulder System Short Humeral Diaphysis (2018), 3 descendants of its own
- K231657: AGILON® XO Shoulder Replacement System (2024), 2 descendants of its own
- K210207: Humeral Eccentric Reverse Metaphysis (2021), 2 descendants of its own
- K250644: MSS - Monobloc stem (2026), 1 descendant 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 and 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 for the device to offer full function in vivo. The glenoid baseplate is intended for cementless application with the addition of screws for primary stability.

Source page: https://510kreport.com/device/K170452
Methodology: https://510kreport.com/methodology