510(k) · Cleared
ClearedDvo Extended Articulation Humeral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dvo Extremity Solutions, LLC · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Feb 19, 2008 as substantially equivalent to K000575 (DePuy Orthopaedics, Inc., 2000) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 19, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911686 (1991). 9 ancestors in all, the oldest K905786 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- This deviceK073331 Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC · 2008
- Descendant · cites it directly · 2 of its ownK080990 Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK203230 Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
- Descendant · 2 generations on · 0 of its ownK112900 SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012
Most influential descendants
Showing 3 of 3 · See all- K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008 · cites it directly2descendants
- K203230Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021 · 2 generations on0descendants
- K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| 0 (this device) | K073331 | Dvo Extended Articulation Humeral Heads | Dvo Extremity Solutions, LLC | 2008 | — |
| +1 | K080990 | Depuy Global C.AP. Cta Resurfacing Shoulder | DePuy Orthopaedics, Inc. | 2008 | — |
| +2 | K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021 | — |
| +2 | K112900 | SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads | Lima Corporate S.P.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 1…21 CFR 888.3690, Class 11, 87 HSD PREDICATE DEVICES: DePuy Global Advantage Extended Humeral Heads, K000575 DVO Total and Hemni Shoulder System, K060988 DEVICE DESCRIPTION: The Extended Articulatio… | 2000 |
| * | K060988 | Total and Hemi Shoulder SystemSummary page 1…Puy Global Advantage Extended Humeral Heads, K000575 DVO Total and Hemni Shoulder System, K060988 DEVICE DESCRIPTION: The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hem… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080990 | Depuy Global C.AP. Cta Resurfacing Shoulder | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K080990 (DePuy Orthopaedics, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K000575.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073331 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073331: Dvo Extended Articulation Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073331
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026