510(k) · Cleared
ClearedStorm Operating Kit, Model 1-10-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Orthopaedics, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Jul 18, 2006 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 2 other predicates after a 39-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jul 18, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960385 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- This deviceK061607 Storm Operating Kit, Model 1-10-0Intelligent Orthopaedics, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK111001 Sterile Storm (R) Operating KitIntelligent Orthopaedics, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111001Sterile Storm (R) Operating KitIntelligent Orthopaedics, Ltd. · 2011 · cites it directly0descendants
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) | K061607 | Storm Operating Kit, Model 1-10-0 | Intelligent Orthopaedics, Ltd. | 2006 | — |
| +1 | K111001 | Sterile Storm (R) Operating Kit | Intelligent Orthopaedics, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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 2…Page 1 of2 E- I Substantial Equivalence The components of the ST(DRMTM Operating Kit are substantially equivalent to K960385 - Sterile Kirschner Wires and Steimann Pins, DePuy; K983121 - Non-Sterile Kirschner wires and Steinmann Pins, Syntec-Tai… | 1996 |
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 2…l Equivalence The components of the ST(DRMTM Operating Kit are substantially equivalent to K960385 - Sterile Kirschner Wires and Steimann Pins, DePuy; K983121 - Non-Sterile Kirschner wires and Steinmann Pins, Syntec-Taichung Medical Instruments co Ltd and K043185- Synth… | 1998 |
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 2…rile Kirschner Wires and Steimann Pins, DePuy; K983121 - Non-Sterile Kirschner wires and Steinmann Pins, Syntec-Taichung Medical Instruments co Ltd and K043185- Synthes 3.5mm Cortex Screws, Synthes. Equivalency is based on similarities in intended use, materials and design to the… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111001 | Sterile Storm (R) Operating Kit | 2011 | 0 |
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 STDRMTM Operating Kit is used in conjunction with the STORMTM in the reduction and fixation of fractures of the lower leg or distal femur
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061607: Storm Operating Kit, Model 1-10-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061607
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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