510(k) · Cleared
Recalled · 2008Reunion HA Fracture Stem
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 May 4, 2007 after a 29-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- May 4, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a 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? (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 |
|---|---|---|---|
| * | — | Solar® ReUnionTM Fracture Stem Named without a submission 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2008 | Not classified | Z-0901-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
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. 2007, this device’s year, is highlighted.
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?
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/K070963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070963: Reunion HA Fracture Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070963
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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