510(k) · Cleared
ClearedHammertoe Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 25, 2013 as substantially equivalent to K110445 (Nextremity Solutions, LLC, 2011) and 2 other predicates after a 119-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Jul 25, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960385 (1996). 9 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 2 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 1 generation backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- This deviceK130859 Hammertoe Correction SystemArthrosurface, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK183228 HammerToe Compression SystemParagon 28, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK162685 2-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK170350 ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Most influential descendants
Showing 4 of 4 · See all- K183228HammerToe Compression SystemParagon 28, Inc. · 2019 · cites it directly0descendants
- K1626852-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017 · cites it directly0descendants
- K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017 · cites it directly0descendants
- K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −3 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −2 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −1 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| 0 (this device) | K130859 | Hammertoe Correction System | Arthrosurface, Inc. | 2013 | — |
| +1 | K183228 | HammerToe Compression System | Paragon 28, Inc. | 2019 | — |
| +1 | K162685 | 2-Piece Hammertoe Correction System | Life Spine, Inc. | 2017 | — |
| +1 | K170350 | ToeMATE® Hammertoe Correction System | Arthrosurface, Inc. | 2017 | — |
| +1 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K110445 | Flexfusion (TM) Fixation ImplantSummary page 2…d Device are substantially equivalent to the following previously cleared and commercially marketed devices: * Nextremity Solutions, LLC K1 10445 FlexFusionTM Fixation Implant * Wright Medical Technology, Inc. K101165 PRO-TOE TM VO Hammer… | 2011 |
| * | K101165 | Pro-Toe VO Hammertow Implant SystemSummary page 2…es: * Nextremity Solutions, LLC K1 10445 FlexFusionTM Fixation Implant * Wright Medical Technology, Inc. K101165 PRO-TOE TM VO Hammertoe Implant System * Tornier, Inc. K990804 StayFuse C… | 2010 |
| * | K990804 | StayfuseSummary page 2…* Wright Medical Technology, Inc. K101165 PRO-TOE TM VO Hammertoe Implant System * Tornier, Inc. K990804 StayFuse Comparative Mechanical Testing was performed per relevant recognized standards. Results from static and dynamic ca… | 1999 |
What descends from it? (4)
4 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 17 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K183228 (Paragon 28, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K110445.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Indicated for small bone fusion, 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/K130859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130859: Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130859
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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