# K111097: Humelock Cemented Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Fx Solutions
- Decided: Nov 9, 2011 after 203 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911686 (1991). 12 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 47 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.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.

## Most influential descendants
- K123814: Humelock II Cemented Shoulder System (2013), 32 descendants of its own
- K140071: Humelock II Cemented Shoulder System (2014), 31 descendants of its own
- K130759: Humelock II Cementless Shoulder System (2013), 31 descendants of its own
- K150488: Humelock II Reversible Shoulder System (2015), 30 descendants of its own
- K163669: Humeris Shoulder (2017), 20 descendants of its own

## Recalls of this device
- Jun 4, 2018 · Class II · Z-2468-2018: Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
- Jun 4, 2018 · Class II · Z-2469-2018: Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

## Indications for use
The Humelock Cemented Shoulder Prosthesis is indicated for use in 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 Humelock Cemented Shoulder Prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K111097
Methodology: https://510kreport.com/methodology