510(k) Report

510(k) · Cleared

Cleared

WMT Implantable K-Wire

K132895510(k) TraditionalCleared Oct 23, 201337-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 · HTY Pin, Fixation, Smooth

Cleared on Oct 23, 2013 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 2 other predicates after a 37-day review. Its family tree reaches back 4 generations to 1996. 27 later devices descend from it.

Decided
Oct 23, 2013
Review
37 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K960385 (1996). 5 ancestors in all. 27 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2021: 4 descendants cleared2020: 2 descendants cleared2017: 3 descendants cleared2014: 3 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2022: 3 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2023: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant 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 · 2010K120645 · Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition · Wrightmedicaltechnologyinc · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 10 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K120645 · Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition · Wrightmedicaltechnologyinc · 2012K101165 · 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 · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 2 generations backK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
  4. 1 generation backK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
  5. This deviceK132895 WMT Implantable K-WireWrightmedicaltechnologyinc · 2013
  6. Descendant · cites it directly · 20 of its ownK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  7. Descendant · cites it directly · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
  8. Descendant · cites it directly · 6 of its ownK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
  9. Descendant · cites it directly · 4 of its ownK151838 PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015
  10. Descendant · 2 generations on · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2014: 32015: 32017: 32018: 12019: 32020: 22021: 42022: 32023: 22024: 12025: 12026: 1
2014high 4 (2021) · low 0 (2016)2026

Most influential descendants

Showing 5 of 27 · See all
  • K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014 · cites it directly20descendants
  • K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · cites it directly9descendants
  • K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015 · cites it directly6descendants
  • K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015 · cites it directly4descendants
  • K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−3K022599Newdeal K WireNew Deal, S.A.2002—
−2K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
−1K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc2012—
0 (this device)K132895WMT Implantable K-WireWrightmedicaltechnologyinc2013—
+1K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc2014—
+1K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc2014—
+1K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc2015—
+1K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc2015—
+2K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20202

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201430
201530
201730
201810
201930
202020
202140
202230
202320
202410
202510
202610
FIG. 1 — Lineage of K132895, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 HTY? 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 HTY device

  1. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc2010—
*K120645Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition
Summary page 1
…FR 888.3040 - Class. 11 Device Product Code, Device Panel: HTY: Pin, Fixation, Smooth (a)(3). Predicate Device: KI10I1165, K 120645 Pro-Toe VO Hammertoe Implant System and…
Wrightmedicaltechnologyinc2012—
*K022599Newdeal K Wire
Summary page 1
…KI10I1165, K 120645 Pro-Toe VO Hammertoe Implant System and K022599 NEWDEAL K WIRE (a)(4). Device Description The WMT Implantable K-Wires are offered in surgical grade stainless steel. A…
New Deal, S.A.2002—

Also cleared against K101165: 13 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420
K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149
K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156
K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154
K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211
K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191
K200068Arthrex DynaNite K-WireArthrex, Inc.20200
K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, 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 17 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K140148 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 20 descendants of its own.
  • 13 other devices also cite its predicate K101165.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The WMT Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, WMT Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

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 HTY

The HTY category page

  • K262126Cerclage Wires;K-wires;Steinmann PinsMK Medical GmbH · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250315Ronavis – FX (FX-001)AIRS, Inc. · 2025

https://510kreport.com/device/K132895 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132895: WMT Implantable K-Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132895

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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