510(k) · Cleared
ClearedTitanium Versa-Dial Humeral Head Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Sep 10, 2014 as substantially equivalent to K060716 (Biomet Manufacturing Corp, 2006) and 2 other predicates after a 208-day review. Its family tree reaches back 6 generations to 1980. 1 later device descends from it.
- Decided
- Sep 10, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K800494 (1980). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK040610 Versa-Dial Humeral HeadBiomet Manufacturing, Inc. · 2004
- 1 generation backK060716 Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2006
- This deviceK140390 Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2014
- Descendant · cites it directly · 0 of its ownK182799 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −2 | K040610 | Versa-Dial Humeral Head | Biomet Manufacturing, Inc. | 2004 | — |
| −1 | K060716 | Versa-Dial Humeral Head Prosthesis | Biomet Manufacturing Corp | 2006 | — |
| 0 (this device) | K140390 | Titanium Versa-Dial Humeral Head Prosthesis | Biomet Manufacturing Corp | 2014 | — |
| +1 | K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 MBF? 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060716 | Versa-Dial Humeral Head ProsthesisSummary page 4…al/Polymer Cemented (888.3650) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate devices are the Versa-Dial® Humeral Head Prosthesis, K060716 and the Bio-Modular Humeral Heads with IonGuard, K915596 and K030710. Device Description: The Titanium Versa-Dial™ Humeral Head… | 2006 |
| * | K915596 | Biomodular Shoulder Humeral Head W/ IonguardSummary page 4…To Which Substantial Equivalence Is Claimed: The predicate devices are the Versa-Dial® Humeral Head Prosthesis, K060716 and the Bio-Modular Humeral Heads with IonGuard, K915596 and K030710. Device Description: The Titanium Versa-Dial™ Humeral Head Prosthesis consists of a series of various-sized modular… | 1992 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 4…stantial Equivalence Is Claimed: The predicate devices are the Versa-Dial® Humeral Head Prosthesis, K060716 and the Bio-Modular Humeral Heads with IonGuard, K915596 and K030710. Device Description: The Titanium Versa-Dial™ Humeral Head Prosthesis consists of a series of various-sized modular humeral hea… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | 2019 | 0 |
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 34 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K182799 (Arthrex, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060716.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.…
Read the full statement (206 words)
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140390: Titanium Versa-Dial Humeral Head Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140390
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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