510(k) · Cleared
ClearedVersa-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 Jun 12, 2006 as substantially equivalent to K040610 (Biomet Manufacturing, Inc., 2004) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1980. 16 later devices descend from it.
- Decided
- Jun 12, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K800494 (1980). 25 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK040610 Versa-Dial Humeral HeadBiomet Manufacturing, Inc. · 2004
- This deviceK060716 Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 2 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
- Descendant · 3 generations on · 1 of its ownK241817 InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 2 generations on9descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on3descendants
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · 3 generations on1descendant
- K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −1 | K040610 | Versa-Dial Humeral Head | Biomet Manufacturing, Inc. | 2004 | — |
| 0 (this device) | K060716 | Versa-Dial Humeral Head Prosthesis | Biomet Manufacturing Corp | 2006 | — |
| +1 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +2 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +3 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
| +3 | K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040610 | Versa-Dial Humeral HeadSummary page 1…sis (21 CFR §888.3690) Legally Marketed Devices To Which Substantial Equivalence Is Cailmed- * Versa-Dlal" Hunmeral Head ProsthesIs; Blomet ManufacturIng Corp. (K(040610) • 610-Modular® Shoulder Sysbem; Blomiet OrthopedicsInc. (K(30710) * Absolute®D B1-Polar Shoulder System; Blomet Manufacturing… | 2004 |
| Kept off the family tree | K030710 | FDA’s K030710 is Bio-Modular Shoulder System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K002998 | Biomet BI-Polar Shoulder SystemSummary page 1…t ManufacturIng Corp. (K(040610) • 610-Modular® Shoulder Sysbem; Blomiet OrthopedicsInc. (K(30710) * Absolute®D B1-Polar Shoulder System; Blomet Manufacturing Corp. (K(002998) Device Description: The Versa-DialTm Humeral Head Prosthesis consists of a series of various- sized modular humieral headis wit… | 2000 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K202716 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 13 descendants of its own.
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.
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?
The Versa-Dial Humeral Head Prosthesis is intended 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 tear arthropathy, where other…
Read the full statement (166 words)
The Versa-Dial Humeral Head Prosthesis is intended 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 tear 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, and the glenoid components of the Bio-Modular Shoulder System.
The device is a single-use implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060716: Versa-Dial Humeral Head Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060716
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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