510(k) · Cleared
ClearedSterile Kirschner Wires and Steinmann Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HTY Pin, Fixation, Smooth
Cleared on Mar 27, 1996 after a 61-day review. The FDA summary names its predicate without a number. 146 later devices descend from it.
- Decided
- Mar 27, 1996
- Review
- 61 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
146 later devices descend from it, 17 citing it directly.
- This deviceK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- Descendant · cites it directly · 118 of its ownK022599 Newdeal K WireNew Deal, S.A. · 2002
- Descendant · 2 generations on · 80 of its ownK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
- Descendant · 2 generations on · 72 of its ownK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- Descendant · 2 generations on · 61 of its ownK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 37 of its ownK070555 Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K022599Newdeal K WireNew Deal, S.A. · 2002 · cites it directly118descendants
- K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010 · 2 generations on80descendants
- K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007 · 2 generations on72descendants
- K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012 · 2 generations on61descendants
- K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007 · cites it directly37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| +1 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| +2 | K101165 | Pro-Toe VO Hammertow Implant System | Wrightmedicaltechnologyinc | 2010 | — |
| +2 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| +2 | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K070555 | Orthopro Steinman Pins and Kirschner Wires | Orthopro, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 18 | 0 |
| 2015 | 14 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 6 | 0 |
| 2019 | 8 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | — | DePuy Non-sterile Kirschner Wires and Steinmann Pins Named without a submission number |
What descends from it? (146)
See all 14617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022599 | Newdeal K Wire | 2002 | 118 |
| K070555 | Orthopro Steinman Pins and Kirschner Wires | 2007 | 37 |
| K030336 | Kmedic External Fixation Devices | 2003 | 16 |
| K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | 2011 | 8 |
| K102215 | Kirschner Wires, Steinman Pins | 2010 | 6 |
| K112254 | Apex Kirschner Wires and Steinmann Pins | 2011 | 5 |
| K063589 | Gso Bone Fixation Fasteners | 2007 | 4 |
| K071035 | Ifs Bone Fixation Devices | 2007 | 3 |
| K170326 | dynaMX Intramedullary Implant | 2017 | 2 |
| K181425 | APTUS® Proximal Humerus System | 2018 | 1 |
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, K022599 (New Deal, S.A., 2002) has gone furthest, with 118 descendants of its own.
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 Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
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/K960385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960385: Sterile Kirschner Wires and Steinmann Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960385
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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