510(k) · Cleared
ClearedOrthopro Steinman Pins and Kirschner Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopro, LLC · HTY Pin, Fixation, Smooth
Cleared on Jul 13, 2007 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1996. 37 later devices descend from it.
- Decided
- Jul 13, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960385 (1996). 2 ancestors in all. 37 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- This deviceK070555 Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007
- Descendant · cites it directly · 27 of its ownK113006 I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
- Descendant · 2 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 4 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · 2 generations on · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012 · cites it directly27descendants
- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 3 generations on15descendants
- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 4 generations on14descendants
- K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| 0 (this device) | K070555 | Orthopro Steinman Pins and Kirschner Wires | Orthopro, LLC | 2007 | — |
| +1 | K113006 | I-Fuse Hammer Toe Systems | Orthopro, LLC | 2012 | — |
| +2 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| +4 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +2 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 1…DW pin, fixation, threaded Predicate or legally marketed devices which are substantially equivalent: DePuy Steinman Pins and K-irshner Wires K960385 Smith and Nephew Pins and Wires K994143 Smith and Nephew Pins and Wires… | 1996 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 1…e substantially equivalent: DePuy Steinman Pins and K-irshner Wires K960385 Smith and Nephew Pins and Wires K994143 Smith and Nephew Pins and Wires Pre-amendment Device Description The OrthoPro Steinman Pins and… | 2000 |
| * | — | Smith and Nephew Pins and Wires Named without a submission number |
What descends from it? (37)
See all 374 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. 2007, 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 OrthoPro Steinman Pins and Kirschner Wires 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 as stated in the FDA summary.
https://510kreport.com/device/K070555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070555: Orthopro Steinman Pins and Kirschner Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070555
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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