510(k) · Cleared
Recalled · 2007Solar Reunion Fracture Stem
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 Oct 3, 2006 after a 71-day review. The FDA summary names its predicate without a number. 44 later devices descend from it. It has been recalled once.
- Decided
- Oct 3, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 0
44 later devices descend from it, 2 citing it directly.
- This deviceK062113 Solar Reunion Fracture StemHowmedica Osteonics Corp. · 2006
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K062113 | Solar Reunion Fracture Stem | Howmedica Osteonics Corp. | 2006 | — |
| +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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Solar® Shoulder Humeral Components Named without a submission number | |
| * | — | Solar® PureFix® HA Shoulder Named without a submission number | |
| * | — | Tornier Aequalis Shoulder Fracture System Named without a submission number |
What descends from it? (44)
See all 442 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2007 | Not classified | Z-0080-2008 | Process control | The plasma spray may delaminate from the proximal portion of the humeral stem. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103835 (Howmedica Osteonics Corp., 2011) has gone furthest, with 43 descendants of its own.
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?
For use as a Bipolar Shoulder Replacement: * 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 fractures and/or dislocation. * Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. * Pathological conditions or age considerations…
Read the full statement (144 words)
For use as a Bipolar Shoulder Replacement:
* 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 fractures and/or dislocation.
* Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
* Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
* 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 fractures and/or dislocation.
* Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
* Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062113: Solar Reunion Fracture Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062113
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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