510(k) · Cleared
ClearedPro-Toe VO Hammertow Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Jul 23, 2010 as substantially equivalent to K022599 (New Deal, S.A., 2002) after an 88-day review. Its family tree reaches back 2 generations to 1996. 80 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960385 (1996). 3 ancestors in all. 80 later devices descend from it, 14 citing it directly.
- Root · 2 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 1 generation backK022599 Newdeal K WireNew Deal, S.A. · 2002
- This deviceK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
- Descendant · cites it directly · 61 of its ownK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- Descendant · cites it directly · 30 of its ownK111536 Metasurg Digifuse ImplantMetasurg · 2011
- Descendant · cites it directly · 27 of its ownK132895 WMT Implantable K-WireWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 22 of its ownK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012 · cites it directly61descendants
- K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
- K111536Metasurg Digifuse ImplantMetasurg · 2011 · cites it directly30descendants
- K132895WMT Implantable K-WireWrightmedicaltechnologyinc · 2013 · cites it directly27descendants
- K122959Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · 2 generations on22descendants
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 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| 0 (this device) | K101165 | Pro-Toe VO Hammertow Implant System | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| +1 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| +1 | K132895 | WMT Implantable K-Wire | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 11 | 0 |
| 2015 | 11 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K022599 | Newdeal K WireSummary page 1…87 Orthopedics A.3. Predicate Device: newdeal®D K-Wire (K022599) A.4. Device Description The PRO-TOETm VO H-amnmertoe Implant System will be offered… | 2002 |
What descends from it? (80)
See all 8014 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition | 2012 | 61 |
| K111536 | Metasurg Digifuse Implant | 2011 | 30 |
| K132895 | WMT Implantable K-Wire | 2013 | 27 |
| K140148 | Pro-Toe Hammertoe Fixation System | 2014 | 20 |
| K100926 | Arrowhead Fixation Device | 2010 | 10 |
| K130859 | Hammertoe Correction System | 2013 | 4 |
| K130412 | Osteomed Extremifuse System | 2013 | 4 |
| K142490 | ProxiFuse Hammer Toe Device | 2014 | 2 |
| K141937 | Trident Fusion Implant | 2014 | 1 |
| K211944 | Medline UNITE® Digital Fusion Screw System | 2021 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120645 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 61 descendants of its own.
- 22 other devices also cite its predicate K022599.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 PRO-TOE TM VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101165: Pro-Toe VO Hammertow Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101165
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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