510(k) · Cleared
ClearedSolar 2 Anatomic Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Jan 7, 2005 after a 323-day review. The FDA summary names no predicate by number.
- Decided
- Jan 7, 2005
- Review
- 323 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is meant to replace the natural humeral head and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cemented and uncemented use. The glenoid component is for cemented use only. The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include: *…
Read the full statement (140 words)
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is meant to replace the natural humeral head and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cemented and uncemented use. The glenoid component is for cemented use only.
The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include:
* 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.
Clinical management problems where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results.
Additional indications for use as a total shoulder include:
* Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040432: Solar 2 Anatomic Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040432
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026