# K130759: Humelock II Cementless Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Fx Solutions
- Decided: Nov 9, 2013 after 234 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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 K943462 (1994). 36 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992525: Acumed Modular Shoulder System, Acu Med, Inc. (2000) Summary page 1.
- K111097: Humelock Cemented Shoulder Prosthesis, Fx Solutions (2011) Summary page 1.
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K103835: Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N, Howmedica Osteonics Corp. (2011) 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 Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.

Source page: https://510kreport.com/device/K130759
Methodology: https://510kreport.com/methodology