510(k) Report

510(k) · Cleared

Cleared

Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition

K120645510(k) TraditionalCleared Apr 24, 201253-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone

Cleared on Apr 24, 2012 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1996. 61 later devices descend from it.

Decided
Apr 24, 2012
Review
53 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K960385 (1996). 4 ancestors in all. 61 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2017: 5 descendants cleared2014: 7 descendants cleared2013: 1 descendant cleared2021: 7 descendants cleared2020: 4 descendants cleared2015: 9 descendants cleared2019: 7 descendants cleared2022: 3 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2026: 4 descendants cleared2023: 4 descendants cleared2024: 4 descendants cleared2025: 3 descendants clearedK960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996K022599 · Newdeal K Wire · New Deal, S.A. · 2002K101165 · Pro-Toe VO Hammertow Implant System · Wrightmedicaltechnologyinc · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 20 descendants3 generations forward: 13 descendants4 generations forward: 6 descendants5 generations forward: 8 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants K101165 · Pro-Toe VO Hammertow Implant System · Wrightmedicaltechnologyinc · 2010K022599 · Newdeal K Wire · New Deal, S.A. · 2002K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 19960+5
  1. Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 1 generation backK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
  4. This deviceK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
  5. Descendant · cites it directly · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  6. Descendant · cites it directly · 27 of its ownK132895 WMT Implantable K-WireWrightmedicaltechnologyinc · 2013
  7. Descendant · cites it directly · 20 of its ownK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  8. Descendant · 2 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  9. Descendant · 3 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2013: 12014: 72015: 92016: 22017: 52018: 12019: 72020: 42021: 72022: 32023: 42024: 42025: 32026: 4
2013high 9 (2015) · low 1 (2013)2026

Most influential descendants

Showing 5 of 61 · See all
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · cites it directly31descendants
  • K132895WMT Implantable K-WireWrightmedicaltechnologyinc · 2013 · cites it directly27descendants
  • K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014 · cites it directly20descendants
  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on16descendants
  • K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 3 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−2K022599Newdeal K WireNew Deal, S.A.2002—
−1K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
0 (this device)K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc2012—
+1K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+1K132895WMT Implantable K-WireWrightmedicaltechnologyinc2013—
+1K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc2014—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201470
201590
201620
201750
201810
201970
202040
202170
202230
202340
202440
202530
202640
FIG. 1 — Lineage of K120645, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
*K022599Newdeal K Wire
Summary page 1
…KIOl 165 - Pro-Toe VO Hammertoe Implant System K022599 - Newdealg K-Wire (a)(4). Device Description The subject implants are modified from the previously cleared Pro-ToeTM VO Ham…
New Deal, S.A.2002—

Also cleared against K101165: 13 other devices →

What descends from it? (61)

See all 61

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431
K132895WMT Implantable K-WireWrightmedicaltechnologyinc201327
K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420
K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas20142
K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141
K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170
K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140

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 3 companies; a new generation was cleared every 6.6 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K133636 (Extremity Medical, LLC, 2014) has gone furthest, with 31 descendants of its own.
  • 13 other devices also cite its predicate K101165.

How does its category compare?

All HWC devices

HWC 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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Pro-ToeTM 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.

Also cleared against K101165

13 other devices cite the same predicate.

  • K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc. · 2021
  • K191424Interphalangeal Joint Fusion Device RangeNeosteo · 2019
  • K172485Footmotion HammerToeNewclip Technics · 2018
  • K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017
  • K142490ProxiFuse Hammer Toe DeviceCartiva, Inc. · 2014
  • K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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https://510kreport.com/device/K120645 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120645

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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