# K073331: Dvo Extended Articulation Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Dvo Extremity Solutions, LLC
- Decided: Feb 19, 2008 after 84 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: 4 generations back to K911686 (1991). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K060988: Total and Hemi Shoulder System, Dvo Extremity Solutions, LLC (2006) Summary page 1.

## Most influential descendants
- K080990: Depuy Global C.AP. Cta Resurfacing Shoulder (2008), 2 descendants of its own
- K203230: Global Shoulder and Delta CTA systems (2021), 0 descendants of its own
- K112900: SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads (2012), 0 descendants of its own

## Indications for use
The DVO Tm Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. 3. Rotator cuff tear arthropathy. Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.

Source page: https://510kreport.com/device/K073331
Methodology: https://510kreport.com/methodology