510(k) · Cleared
ClearedResorbable Hammertoe Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDW Pin, Fixation, Threaded
Cleared on Jun 19, 2001 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Jun 19, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK011137 Resorbable Hammertoe PinBiomet, Inc. · 2001
- Descendant · cites it directly · 14 of its ownK021828 Small Hammer Toe PinBiomet, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK100414 Protoe Endosorb Small Hammer Toe PinMerete Medical GmbH · 2010
- Descendant · 2 generations on · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- Descendant · 4 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K021828Small Hammer Toe PinBiomet, Inc. · 2002 · cites it directly14descendants
- K100414Protoe Endosorb Small Hammer Toe PinMerete Medical GmbH · 2010 · cites it directly13descendants
- K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · 2 generations on10descendants
- K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · 3 generations on9descendants
- K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011137 | Resorbable Hammertoe Pin | Biomet, Inc. | 2001 | — |
| +1 | K021828 | Small Hammer Toe Pin | Biomet, Inc. | 2002 | — |
| +1 | K100414 | Protoe Endosorb Small Hammer Toe Pin | Merete Medical GmbH | 2010 | — |
| +2 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| +3 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| +4 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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?
- Of its descendants, K021828 (Biomet, Inc., 2002) has gone furthest, with 14 descendants 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 | — |
https://510kreport.com/device/K011137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011137: Resorbable Hammertoe Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011137
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026