# K140071: Humelock II Cemented Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fx Solutions
- Decided: Jul 28, 2014 after 196 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911686 (1991). 20 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123814: Humelock II Cemented Shoulder System, Fx Solutions (2013) Summary page 1.
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.

## Most influential descendants
- K150488: Humelock II Reversible Shoulder System (2015), 30 descendants of its own
- 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

## Indications for use
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: 1. Proximal humeral fractures 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

Source page: https://510kreport.com/device/K140071
Methodology: https://510kreport.com/methodology