510(k) · Cleared
ClearedI-Fuse Hammer Toe Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopro, LLC · HWC Screw, Fixation, Bone
Cleared on May 25, 2012 as substantially equivalent to K990804 (Pioneer Surgical Technology, 1999) and 1 other predicate after a 231-day review. Its family tree reaches back 2 generations to 1996. 27 later devices descend from it.
- Decided
- May 25, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960385 (1996). 4 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 1 generation backK070555 Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007
- This deviceK113006 I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
- Descendant · cites it directly · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 3 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · cites it directly · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · 4 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 2 generations on15descendants
- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 3 generations on14descendants
- K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · cites it directly9descendants
- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 4 generations on7descendants
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 | K070555 | Orthopro Steinman Pins and Kirschner Wires | Orthopro, LLC | 2007 | — |
| 0 (this device) | K113006 | I-Fuse Hammer Toe Systems | Orthopro, LLC | 2012 | — |
| +1 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| +3 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +1 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +4 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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 |
|---|---|---|---|
| * | K990804 | StayfuseSummary page 1…CFR section: 21 CER section 888.3040 Device panel: Orthopedic Legally Marketed Stayfuse, Pioneer Surgical Technology, K990804 Predicate Device: OthoPro Stemnman Pins and Kirschner Wires, OrthoPro LLC, K070555 Submitter:… | 1999 |
| * | K070555 | Orthopro Steinman Pins and Kirschner WiresSummary page 1…ic Legally Marketed Stayfuse, Pioneer Surgical Technology, K990804 Predicate Device: OthoPro Stemnman Pins and Kirschner Wires, OrthoPro LLC, K070555 Submitter: OrthPro, LLC 3450 S Highland Dr.… | 2007 |
What descends from it? (27)
See all 272 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 16 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141857 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K990804.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113006: I-Fuse Hammer Toe Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113006
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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