510(k) · Cleared
ClearedBone Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stork Instrumente GmbH · HTY Pin, Fixation, Smooth
Cleared on Mar 25, 2003 as substantially equivalent to K961522 (Synvasive Technology, Inc., 1996) after a 22-day review. Its family tree reaches back 1 generation to 1996. 113 later devices descend from it.
- Decided
- Mar 25, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K961522 (1996). 113 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- This deviceK030665 Bone WireStork Instrumente GmbH · 2003
- Descendant · cites it directly · 65 of its ownK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- Descendant · cites it directly · 48 of its ownK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- Descendant · 2 generations on · 24 of its ownK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- Descendant · 3 generations on · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
- Descendant · cites it directly · 12 of its ownK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010 · cites it directly65descendants
- K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH · 2009 · cites it directly48descendants
- K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG · 2012 · 2 generations on24descendants
- K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · 3 generations on15descendants
- K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| 0 (this device) | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| +1 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| +1 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| +2 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| +3 | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
| +1 | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 9 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K083121 | FDA’s K083121 is Neo Mapcath Sensor Stylet Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| Kept off the family tree | K071862 | Bone Wires (Steinmann Pins), Osteonics Corporation Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K060385 | FDA’s K060385 is Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K961522 | Kirschner Wire (K-Wire) and Steinmann PinSummary page 2…keted by many companies including .. Syntec-Taichung Co., Ltd., #Kg83121 Osteonics Corporation, #Kg71862 DePuy Inc., #Kg60385 . Synvasive Technology Inc., #961522 5. 6lOCOMPATlBlLlTY The biocompatibility is guaranteed by the composition of the used materials as mentioned in chapter 6. These… | 1996 |
| † | K983758 | Yasargil Titanium Aneurysm Clips | 1998 |
| † | K000080 | Asnis Iii Cannulated Screw System | 2000 |
| † | K003500 | Rebstock Yasargil Aneurysm Clip | 2001 |
What descends from it? (113)
See all 1133 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?
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 intended use of Stork lnstrumente GmbH's Bone Wires is the fixation of bone fractures and / or to
guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L)
or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Stork lnstrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize
these devices by using a validated and applicable sterilization process.
Stork lnstrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle
of 134°C / 270"F, 3 bar, for 10 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030665: Bone Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030665
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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