510(k) · Cleared
ClearedHansson Pin 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 Feb 20, 2004 as substantially equivalent to K964893 (Osteonics Corp., 1997) after a 60-day review. Its family tree reaches back 2 generations to 1976. 1 later device descends from it.
- Decided
- Feb 20, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K760454 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK760454 Gouffon Pin, AdjustableHowmedica Corp. · 1976
- 1 generation backK964893 Hansson Pin SystemOsteonics Corp. · 1997
- This deviceK033968 Hansson Pin SystemHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 0 of its ownK131591 Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K131591Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)Pega Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760454 | Gouffon Pin, Adjustable | Howmedica Corp. | 1976 | — |
| −1 | K964893 | Hansson Pin System | Osteonics Corp. | 1997 | — |
| 0 (this device) | K033968 | Hansson Pin System | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K131591 | Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) | Pega Medical, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K964893 | Hansson Pin SystemSummary page 1…treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson' Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension ch… | 1997 |
| * | — | ASNIS II & III Cannulated Bone Screws Named without a submission number |
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 |
|---|---|---|---|
| K131591 | Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) | 2013 | 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 28 years and passes through 3 companies; a new generation was cleared every 20.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131591 (Pega Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K964893.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hansson Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:
* Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck Fractures
* Basal Neck Fractures
* Slipped Capital Femoral Epiphysis (in pediatric patients)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033968 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033968: Hansson Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033968
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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