510(k) · Cleared
ClearedMonospherical Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Sep 16, 1980 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 416 devices in its family, counting itself, has a Class I recall. 415 later devices descend from it.
- Decided
- Sep 16, 1980
- Review
- 12 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
415 later devices descend from it, 1 citing it directly. 1 of the 416 devices in this family, counting this one, has a Class I recall.
- This deviceK802123 Monospherical Shoulder ProsthesisHowmedica Corp. · 1980
- Descendant · cites it directly · 414 of its ownK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- Descendant · 2 generations on · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · 3 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · 2 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · 2 generations on · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
Showing 5 of 415 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations on · 2008
Most influential descendants
Showing 5 of 415 · See all- K991585Bipolar Shoulder ProsthesisBiomet, Inc. · 1999 · cites it directly414descendants
- K021478Delta ShoulderDepuy, Inc. · 2003 · 2 generations on338descendants
- K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · 3 generations on295descendants
- K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 2 generations on280descendants
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 2 generations on277descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802123 | Monospherical Shoulder Prosthesis | Howmedica Corp. | 1980 | — |
| +1 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| +2 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +3 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +2 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 1 |
| 2009 | 2 | 0 |
| 2010 | 9 | 0 |
| 2011 | 16 | 0 |
| 2012 | 20 | 0 |
| 2013 | 21 | 0 |
| 2014 | 18 | 0 |
| 2015 | 15 | 0 |
| 2016 | 18 | 0 |
| 2017 | 21 | 0 |
| 2018 | 24 | 0 |
| 2019 | 26 | 0 |
| 2020 | 25 | 0 |
| 2021 | 32 | 0 |
| 2022 | 24 | 0 |
| 2023 | 23 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 28 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (415)
See all 4151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991585 | Bipolar Shoulder Prosthesis | 1999 | 414 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991585 (Biomet, Inc., 1999) has gone furthest, with 414 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K802123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K802123: Monospherical Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802123
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026