510(k) · Cleared
ClearedProxiFuse Hammer Toe Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cartiva, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 15, 2014 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 2 other predicates after a 102-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 15, 2014
- Review
- 102 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960385 (1996). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
- This deviceK142490 ProxiFuse Hammer Toe DeviceCartiva, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK142478 opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica) · 2015
- Descendant · 2 generations on · 0 of its ownK162685 2-Piece Hammertoe Correction SystemLife Spine, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K101165 | Pro-Toe VO Hammertow Implant System | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K142490 | ProxiFuse Hammer Toe Device | Cartiva, Inc. | 2014 | — |
| +1 | K142478 | opti-Toe | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 2015 | — |
| +2 | K162685 | 2-Piece Hammertoe Correction System | Life Spine, Inc. | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K101165 | Pro-Toe VO Hammertow Implant SystemSummary page 4…ation Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Predicate Device(s): Pro-Toe VO Hammertoe Implant System, K101165 NEWDEAL K WIRE, K022599 Arthrex Bio-Pin (marketed as Trim-It Pin), K050259 Devic… | 2010 |
| * | K022599 | Newdeal K WireSummary page 4…fixation fastener (21 CFR 888.3040) Predicate Device(s): Pro-Toe VO Hammertoe Implant System, K101165 NEWDEAL K WIRE, K022599 Arthrex Bio-Pin (marketed as Trim-It Pin), K050259 Device Description: The ProxiFuse Hammer Toe Devi… | 2002 |
| * | K050259 | Arthrex Bio-PinSummary page 4…ce(s): Pro-Toe VO Hammertoe Implant System, K101165 NEWDEAL K WIRE, K022599 Arthrex Bio-Pin (marketed as Trim-It Pin), K050259 Device Description: The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2)… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142478 | opti-Toe | 2015 | 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K142478 (Graham Medical Technologies, LLC (D.B.A.Gramedica), 2015) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K101165.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
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/K142490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142490: ProxiFuse Hammer Toe Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142490
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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