510(k) · Cleared
ClearedSolar Shoulder Offset Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Jul 27, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 110 later devices descend from it.
- Decided
- Jul 27, 2000
- Review
- 83 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
110 later devices descend from it, 2 citing it directly.
- This deviceK001419 Solar Shoulder Offset Humeral HeadHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- Descendant · cites it directly · 43 of its ownK103835 Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model…Howmedica Osteonics Corp. · 2011 · Recalled
- Descendant · 2 generations on · 31 of its ownK130759 Humelock II Cementless Shoulder SystemFx Solutions · 2013
- Descendant · 3 generations on · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · 2 generations on · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
- K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp. · 2011 · cites it directly43descendants
- K130759Humelock II Cementless Shoulder SystemFx Solutions · 2013 · 2 generations on31descendants
- K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · 3 generations on30descendants
- K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001419 | Solar Shoulder Offset Humeral Head | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| +1 | K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX… | Howmedica Osteonics Corp. | 2011 | 1 |
| +2 | K130759 | Humelock II Cementless Shoulder System | Fx Solutions | 2013 | — |
| +3 | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +2 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (110)
See all 1102 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?
- Of its descendants, K042021 (Exactech, Inc., 2004) has gone furthest, with 71 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/K001419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001419: Solar Shoulder Offset 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/K001419
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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