510(k) · Cleared
ClearedOsteonics Solar Shoulder Humeral Bearing Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Mar 15, 1999 as substantially equivalent to K955731 (Osteonics Corp., 1996) after a 19-day review. Its family tree reaches back 1 generation to 1996. 44 later devices descend from it.
- Decided
- Mar 15, 1999
- Review
- 19 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955731 (1996). 44 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK955731 Osteonics Shoulder Humeral ComponentsOsteonics Corp. · 1996 · Recalled
- This deviceK990598 Osteonics Solar Shoulder Humeral Bearing HeadHowmedica Osteonics Corp. · 1999
- 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 · 4 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
- Descendant · 4 generations on · 17 of its ownK162455 Humelock Reversed ShoulderFx Solutions · 2017
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- 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
- K163669Humeris ShoulderFx Solutions · 2017 · 4 generations on20descendants
- K162455Humelock Reversed ShoulderFx Solutions · 2017 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955731 | Osteonics Shoulder Humeral Components | Osteonics Corp. | 1996 | 1 |
| 0 (this device) | K990598 | Osteonics Solar Shoulder Humeral Bearing Head | Howmedica Osteonics Corp. | 1999 | — |
| +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 | — |
| +4 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| +4 | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | K955731 | Osteonics Shoulder Humeral ComponentsSummary page 1…features of the following Osteonics® predicate devices, which have been cleared for marketing via the 510(k) process: ® Osteonics® Solar Shoulder Humeral Bearing Head (#K955731) Device Description The Osteonics® Solar Shoulder Humeral Bearing Heads are currently marketed devices that are being modified.… | 1996 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C… | 2011 | 43 |
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?
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?
The indications for the use of the Osteonics® Solar Shoulder Humeral Bearing Head , in keeping with those of other legally marketed Osteonics® shoulder components, are as follows:
Indications
Aseptic necrosis of the humeral head.
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Proximal humeral fracture and/or dislocation.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990598: Osteonics Solar Shoulder Humeral Bearing Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990598
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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