510(k) · Cleared
ClearedProtoe Endosorb Small Hammer Toe Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · JDW Pin, Fixation, Threaded
Cleared on Jul 2, 2010 as substantially equivalent to K021828 (Biomet, Inc., 2002) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it.
- Decided
- Jul 2, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011137 (2001). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK011137 Resorbable Hammertoe PinBiomet, Inc. · 2001
- 1 generation backK021828 Small Hammer Toe PinBiomet, Inc. · 2002
- This deviceK100414 Protoe Endosorb Small Hammer Toe PinMerete Medical GmbH · 2010
- Descendant · cites it directly · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- Descendant · 3 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
- Descendant · 4 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · cites it directly10descendants
- K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · 2 generations on9descendants
- K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 3 generations on4descendants
- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 4 generations on3descendants
- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011137 | Resorbable Hammertoe Pin | Biomet, Inc. | 2001 | — |
| −1 | K021828 | Small Hammer Toe Pin | Biomet, Inc. | 2002 | — |
| 0 (this device) | K100414 | Protoe Endosorb Small Hammer Toe Pin | Merete Medical GmbH | 2010 | — |
| +1 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| +2 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| +3 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
| +4 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +4 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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), 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? (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 |
|---|---|---|---|
| * | K021828 | Small Hammer Toe PinSummary page 1…3040) Product Code: HWC Proposed Regulatory Class: Class Il Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Small Hammer Toe Pin, Biomet, Inc. (K021828); Resorbable Hammertoe Pin, Biomet, Inc. (K011137) intended Use: The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for pr… | 2002 |
| * | K011137 | Resorbable Hammertoe PinSummary page 1…s: Class Il Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Small Hammer Toe Pin, Biomet, Inc. (K021828); Resorbable Hammertoe Pin, Biomet, Inc. (K011137) intended Use: The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis. D… | 2001 |
What descends from it? (13)
See all 134 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K100926 (Arrow Products, Inc., 2010) has gone furthest, with 10 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. 2010, this device’s year, is highlighted.
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 ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
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/K100414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100414: Protoe Endosorb Small Hammer Toe Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100414
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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