510(k) · Cleared
ClearedVersa-Dial Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 4, 2004 as substantially equivalent to K023063 (Biomet Orthopedics, Inc., 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1980. 17 later devices descend from it.
- Decided
- Jun 4, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K800494 (1980). 24 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 3 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 2 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 1 generation backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- This deviceK040610 Versa-Dial Humeral HeadBiomet Manufacturing, Inc. · 2004
- Descendant · cites it directly · 16 of its ownK060716 Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2006
- Descendant · 2 generations on · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 3 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2006 · cites it directly16descendants
- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 3 generations on9descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 3 generations on3descendants
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −3 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −2 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| 0 (this device) | K040610 | Versa-Dial Humeral Head | Biomet Manufacturing, Inc. | 2004 | — |
| +1 | K060716 | Versa-Dial Humeral Head Prosthesis | Biomet Manufacturing Corp | 2006 | — |
| +2 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +3 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +3 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +4 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 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 |
|---|---|---|---|
| * | K023063 | Comprehensive Humeral Fracture SystemSummary page 1…hesis (21 CFR Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Comprehensive Hiumeral Fracture System - Biornet Inc. (K023063) 2. Bio-Modular ® Shoulder System (K030710) Device Description: The Versa-DialTM Humeral Head Prosthes… | 2002 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 1…nce Is Claimed: 1. Comprehensive Hiumeral Fracture System - Biornet Inc. (K023063) 2. Bio-Modular ® Shoulder System (K030710) Device Description: The Versa-DialTM Humeral Head Prosthesis is a metallic humeral head designed to function as the articulatin… | 2003 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060716 | Versa-Dial Humeral Head Prosthesis | 2006 | 16 |
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 24 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K060716 (Biomet Manufacturing Corp, 2006) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K023063.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
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 tear arthropathy, where other methods of treatment may not be suitable or may be…
Read the full statement (123 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 tear arthropathy, where other methods of treatment may not be suitable or may be inadequate.
The Versa-Dial TM Humeral Head Prosthesis is intended for use with the Comprehensive Humeral Fracture Stem for either cemented or uncemented (press-fit) use.
The Versa-Dial TM Humeral Head Prosthesis is intended for use with the glenoid components of the Bio-Modular Shoulder System, either all polyethylene for cemented use or metal backed for uncemented (biological fixation with optional screw fixation) use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040610: Versa-Dial Humeral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040610
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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