# K190738: MyShoulder Placement Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Dec 13, 2019 after 266 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 K905070 (1991). 98 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143374: BLUEPRINT Patient Specific Instrumentation, Tornier S.A.S. (2015) Summary page 4.

## Most influential descendants
- K233992: Precision AI Surgical Planning System (PAI-SPS) (2024), 2 descendants of its own
- K243955: Precision AI Surgical Planning System (PAI-SPS) (2025), 1 descendant of its own
- K251558: Precision AI Surgical Planning System (PAI-SPS) (2026), 0 descendants of its own
- K243509: Archer PSI System (2025), 0 descendants of its own

## Indications for use
The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming. Both anatomical and reverse total joint configurations are acceptable. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use. MyShoulder Patient-Matched Guides are intended for single use only.

Source page: https://510kreport.com/device/K190738
Methodology: https://510kreport.com/methodology