510(k) · Cleared
ClearedStryker Sonicpin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HTY Pin, Fixation, Smooth
Cleared on Apr 2, 2010 after a 275-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 275 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK091955 Stryker Sonicpin SystemHowmedica Osteonics Corp. · 2010
- Descendant · cites it directly · 1 of its ownK143063 Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK170418 Stryker SonicPin SystemStryker Trauma GmbH · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091955 | Stryker Sonicpin System | Howmedica Osteonics Corp. | 2010 | — |
| +1 | K143063 | Stryker SonicPin System, Stryker SonicAnchor System | Stryker Trauma GmbH | 2015 | — |
| +2 | K170418 | Stryker SonicPin System | Stryker Trauma GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | INION OTPS Pin Named without a submission number | |
| * | — | Synthes POLYPIN 2.0 Named without a submission number | |
| * | — | Howmedica Bioabsorbable Pin Named without a submission number | |
| * | — | KLS-Martin, L.P. RESORB-X SF Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143063 | Stryker SonicPin System, Stryker SonicAnchor System | 2015 | 1 |
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, K143063 (Stryker Trauma GmbH, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast, brace). The Stryker SonicPin is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091955: Stryker Sonicpin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091955
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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