510(k) · Cleared
ClearedHansson Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDW Pin, Fixation, Threaded
Cleared on Feb 28, 1997 as substantially equivalent to K760454 (Howmedica Corp., 1976) after an 84-day review. Its family tree reaches back 1 generation to 1976. 2 later devices descend from it.
- Decided
- Feb 28, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760454 (1976). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK760454 Gouffon Pin, AdjustableHowmedica Corp. · 1976
- This deviceK964893 Hansson Pin SystemOsteonics Corp. · 1997
- Descendant · cites it directly · 1 of its ownK033968 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760454 | Gouffon Pin, Adjustable | Howmedica Corp. | 1976 | — |
| 0 (this device) | K964893 | Hansson Pin System | Osteonics Corp. | 1997 | — |
| +1 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K760454 | Gouffon Pin, AdjustableSummary page 1…predicate devices are as follows: Howmedica Knowles Hip Pins (preamendment device), Zimmer Knowles Hip Pins (preamendment device), and Howmedica Gouffon Hip Pin System (K760454). Device Descrinti The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer… | 1976 |
| * | — | Howmedica Knowles Hip Pins Named without a submission number | |
| * | — | Zimmer Knowles Hip Pins Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K033968 (Howmedica Osteonics Corp., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.
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/K964893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964893: 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/K964893
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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