510(k) Report

510(k) · Cleared

Cleared

Footmotion HammerToe

K172485510(k) TraditionalCleared Mar 2, 2018197-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

Newclip Technics · HTY Pin, Fixation, Smooth

Cleared on Mar 2, 2018 as substantially equivalent to K070598 (Memometal Technologies, 2007) and 3 other predicates after a 197-day review. Its family tree reaches back 5 generations to 1996.

Decided
Mar 2, 2018
Review
197 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K960385 (1996). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2005: 1 other ancestor1997: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestorReference device: K050259 · Arthrex Bio-Pin · Arthrex, Inc. · 2005K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996K022599 · Newdeal K Wire · New Deal, S.A. · 2002K070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 2007K110445 · Flexfusion (TM) Fixation Implant · Nextremity Solutions, LLC · 2011 · recalledK122031 · Nextra TI Hammertoe Correction System · Nextremity Solutions, LLC · 2012199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors K122031 · Nextra TI Hammertoe Correction System · Nextremity Solutions, LLC · 2012K110445 · Flexfusion (TM) Fixation Implant · Nextremity Solutions, LLC · 2011 · recalledK070598 · Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse · Memometal Technologies · 2007K022599 · Newdeal K Wire · New Deal, S.A. · 2002K960385 · Sterile Kirschner Wires and Steinmann Pins · Depuy, Inc. · 1996−50
  1. Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
  2. 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
  3. 3 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
  4. 2 generations backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
  5. 1 generation backK122031 Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012
  6. This deviceK172485 Footmotion HammerToeNewclip Technics · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc.1996—
−4K022599Newdeal K WireNew Deal, S.A.2002—
−3K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies2007—
−2K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC20116
−1K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC2012—
0 (this device)K172485Footmotion HammerToeNewclip Technics2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200510
201010
201110
FIG. 1 — Lineage of K172485, 1996–2018Source: 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? (4)

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
*K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Summary page 4
…0) 3. Primary predicate or legally marketed devices which are substantially equivalent: x Memometal Intra-medullary Bone Fastener of MEMOMETAL TECHNOLOGIES (K070598 / K112197) K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.…
Memometal Technologies2007—
*K112197Memometal Intra-Medullary Bone Fastener
Summary page 4
…Primary predicate or legally marketed devices which are substantially equivalent: x Memometal Intra-medullary Bone Fastener of MEMOMETAL TECHNOLOGIES (K070598 / K112197) K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.…
Memometal Technologies20111
*K101165Pro-Toe VO Hammertow Implant System
Summary page 5
…of 3 Secondary predicate or legally marketed devices which are substantially equivalent: x Pro-Toe Vo Hammertoe Implant System of WRIGHT MEDICAL TECHNOLOGIES (K101165) x Nextra Ti Hammertoe Correction System of NEXTREMITY SOLUTION, INC (K122031) Reference predicate or legally marketed dev…
Wrightmedicaltechnologyinc2010—
*K122031Nextra TI Hammertoe Correction System
Summary page 5
…ivalent: x Pro-Toe Vo Hammertoe Implant System of WRIGHT MEDICAL TECHNOLOGIES (K101165) x Nextra Ti Hammertoe Correction System of NEXTREMITY SOLUTION, INC (K122031) Reference predicate or legally marketed devices which are substantially equivalent: x Trim-it drill pin of ARTHREX (K050259)…
Nextremity Solutions, LLC2012—
†K050259Arthrex Bio-PinArthrex, Inc.2005—

Also cleared against K070598: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • 13 other devices also cite its predicate K070598.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K070598

13 other devices cite the same predicate.

  • K173616DIP Arthrodesis SystemIn2bones Sas · 2018
  • K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017
  • K150211EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015
  • K143049LYNC intramedullary implantNovastep · 2015
  • K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  • K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2014

More from Newclip Technics

35 FDA decisions under this applicant name. See the company

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Recent decisions in HTY

The HTY category page

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https://510kreport.com/device/K172485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172485: Footmotion HammerToe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172485

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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