510(k) · Cleared
ClearedIn2Bones Kirschner wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HTY Pin, Fixation, Smooth
Cleared on Feb 1, 2016 as substantially equivalent to K022599 (New Deal, S.A., 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1996. 20 later devices descend from it.
- Decided
- Feb 1, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960385 (1996). 3 ancestors in all. 20 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 1 generation backK022599 Newdeal K WireNew Deal, S.A. · 2002
- This deviceK153204 In2Bones Kirschner wireIn2bones Sas · 2016
- Descendant · cites it directly · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · 2 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- Descendant · cites it directly · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- Descendant · 3 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · cites it directly14descendants
- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 2 generations on7descendants
- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 2 generations on4descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · cites it directly4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −1 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| 0 (this device) | K153204 | In2Bones Kirschner wire | In2bones Sas | 2016 | — |
| +1 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +2 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| +2 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| +1 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| +3 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K022599 | Newdeal K WireSummary page 5…a hospital, or outpatient surgery center, where sterile field may be created and maintained. Predicate Devices NEWDEAL K WIRE (K022599) Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121) Indicati… | 2002 |
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 5…aintained. Predicate Devices NEWDEAL K WIRE (K022599) Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121) Indications for use: The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone… | 1998 |
What descends from it? (20)
See all 206 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 20 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181872 (Crossroads Extremity Systems, LLC, 2019) has gone furthest, with 14 descendants of its own.
- 22 other devices also cite its predicate K022599.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153204: In2Bones Kirschner wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153204
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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