# K150488: Humelock II Reversible Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fx Solutions
- Decided: Nov 13, 2015 after 261 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: 7 generations back to K911686 (1991). 50 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.
- K123814: Humelock II Cemented Shoulder System, Fx Solutions (2013) Summary page 4.
- K140071: Humelock II Cemented Shoulder System, Fx Solutions (2014) Summary page 4.
- K130759: Humelock II Cementless Shoulder System, Fx Solutions (2013) Summary page 4.

## Most influential descendants
- K163669: Humeris Shoulder (2017), 20 descendants of its own
- K162455: Humelock Reversed Shoulder (2017), 17 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K213117: FX V135 Shoulder Prosthesis (2022), 4 descendants of its own
- K192206: 32mm Glenosphere and Humeral Cup (2019), 4 descendants of its own

## Indications for use
The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K150488
Methodology: https://510kreport.com/methodology