# K170910: Medacta Anatomic Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Aug 16, 2017 after 141 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 104 ancestors in all.
8 later devices descend from it; 4 cite it directly.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083439: Synthes Epoca Shoulder Prosthesis System, Synthes (Usa) (2009) Summary page 4.
- K101996: Depuy Global Unite Shoulder System, Depuy (Ireland) (2010) Summary page 4.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 4.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 4.
- K994393: Aequalis Universal Shoulder Glenoid, Tornier (2000) 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
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K241944: AGILON® XO Shoulder Replacement System (2025), 1 descendant of its own

## Recalls of this device
- Nov 4, 2019 · Class II · Z-0775-2020: Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

## 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.

Source page: https://510kreport.com/device/K170910
Methodology: https://510kreport.com/methodology