510(k) · Cleared
ClearedStryker SonicPin System, Stryker SonicAnchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma GmbH · HTY Pin, Fixation, Smooth
Cleared on Jan 27, 2015 as substantially equivalent to K091955 (Howmedica Osteonics Corp., 2010) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jan 27, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K050749 (2005). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
- 1 generation backK063479 Arthrex PushlockArthrex, Inc. · 2006
- This deviceK143063 Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH · 2015
- Descendant · cites it directly · 0 of its ownK170418 Stryker SonicPin SystemStryker Trauma GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K170418Stryker SonicPin SystemStryker Trauma GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050749 | Arthrex Tak Family | Arthrex, Inc. | 2005 | — |
| −1 | K063479 | Arthrex Pushlock | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K143063 | Stryker SonicPin System, Stryker SonicAnchor System | Stryker Trauma GmbH | 2015 | — |
| +1 | K170418 | Stryker SonicPin System | Stryker Trauma GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K091955 | Stryker Sonicpin SystemSummary page 5…Stryker SonicAnchor System: MAI, GAT Predicate Devices: Stryker SonicPin System Primary Predicate: Stryker SonicPin System-K091955 Stryker SonicAnchor System Primary Predicate-Arthrex 2.5 mm PushLock -K063479… | 2010 |
| * | K063479 | Arthrex PushlockSummary page 5…Primary Predicate: Stryker SonicPin System-K091955 Stryker SonicAnchor System Primary Predicate-Arthrex 2.5 mm PushLock -K063479 Reference Device- Stryker SonicPin System-K091955 Date Prepared: October 22, 2014… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170418 | Stryker SonicPin System | 2017 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170418 (Stryker Trauma GmbH, 2017) has gone furthest, with 0 descendants 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. 2015, 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 and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment. The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle knee…
Read the full statement (152 words)
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 and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle knee, hand, wrist, elbow and shoulder. The Stryker SonicAnchor is designed only to be inserted with the SonicFusion equipment.
Indications Include:
Foot/Ankle
* Achilles Tendon Repair
« Lateral Stabilization
» Medial Stabilization
« Hallux Valgus Reconstruction
» Midfoot Reconstruction
» Metatarsal Ligament Repair
« Digital Tendon Transfer
Shoulder
» Acromio-Clavicular Separation Repair
* Proximal Deltoid Repair
Elbow
» Ulnar or Radial Collateral Ligament Reconstruction
Knee
» Patellar Tendon Repair
Hand/Wrist
» Scapholunate Ligament Reconstruction
» Carpal Ligament Reconstruction
* Repair/Reconstruction of Collateral Ligaments
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/K143063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143063: Stryker SonicPin System, Stryker SonicAnchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143063
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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