510(k) Report

510(k) · Cleared

Cleared

Extremity Medical Hammertoe Device

K133636510(k) TraditionalCleared Mar 28, 2014122-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

Extremity Medical, LLC · HWC Screw, Fixation, Bone

Cleared on Mar 28, 2014 as substantially equivalent to K120645 (Wrightmedicaltechnologyinc, 2012) and 5 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1990. 31 later devices descend from it.

Decided
Mar 28, 2014
Review
122 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K901456 (1990). 27 ancestors in all, the oldest K792670 (1980). 31 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 3 other ancestors2008: 1 other ancestor2007: 3 other ancestors2010: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 3 other ancestors2000: 1 other ancestor1996: 2 other ancestors2006: 1 other ancestor2004: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1980: 1 other ancestor2020: 2 descendants cleared2015: 4 descendants cleared2016: 2 descendants cleared2014: 1 descendant cleared2019: 4 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2021: 3 descendants cleared2024: 4 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 4 descendants clearedK901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 1990K031712 · Inion Otps Biodegradable Pin · Inion, Ltd. · 2003K050275 · Modification to: Inion Otps Biodegradable Pin · Inion, Ltd. · 2005K061164 · Activapin · Bioretec, Ltd. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors3 generations back: 8 other ancestors4 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants6 generations forward: 4 descendants K061164 · Activapin · Bioretec, Ltd. · 2006K050275 · Modification to: Inion Otps Biodegradable Pin · Inion, Ltd. · 2005K031712 · Inion Otps Biodegradable Pin · Inion, Ltd. · 2003K901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19900+5
  1. Root · 4 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
  2. 3 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
  3. 2 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
  4. 1 generation backK061164 ActivapinBioretec, Ltd. · 2006
  5. This deviceK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  6. Descendant · cites it directly · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  7. Descendant · 2 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
  8. Descendant · 3 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
  9. Descendant · 4 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
  10. Descendant · cites it directly · 5 of its ownK161449 HammerTech Fixation SystemFusion Orthopedics, LLC · 2016

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2014: 12015: 42016: 22017: 12018: 12019: 42020: 22021: 32023: 22024: 42025: 32026: 4
2014high 4 (2015) · low 0 (2022)2026

Most influential descendants

Showing 5 of 31 · See all
  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly16descendants
  • K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 2 generations on15descendants
  • K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 3 generations on14descendants
  • K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 4 generations on7descendants
  • K161449HammerTech Fixation SystemFusion Orthopedics, LLC · 2016 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K901456Orthosorb (R) Absorbable PinJohnson & Johnson International1990—
−3K031712Inion Otps Biodegradable PinInion, Ltd.2003—
−2K050275Modification to: Inion Otps Biodegradable PinInion, Ltd.2005—
−1K061164ActivapinBioretec, Ltd.2006—
0 (this device)K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+1K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+2K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC2015—
+3K181872MIS Bunion SystemCrossroads Extremity Systems, LLC2019—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.2023—
+1K161449HammerTech Fixation SystemFusion Orthopedics, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199620
199720
199810
200010
200130
200220
200310
200410
200610
200730
200810
201010
201230

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201540
201620
201710
201810
201940
202020
202130
202320
202440
202530
202640
FIG. 1 — Lineage of K133636, 1990–2026Source: 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? (6)

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
*K120645Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition
Summary page 1
…bone fixation fastener and Number 21 CFR 888.3040 Product Code HWC (screw, fixation, bone) Predicate Devices K 120645 - PRO-TOE"" VO Hammertoe Implant System (Wright Medical) K120165 - Intraosseous Fixation System…
Wrightmedicaltechnologyinc2012—
*K120165Intraosseous Fixation System
Summary page 1
…HWC (screw, fixation, bone) Predicate Devices K 120645 - PRO-TOE"" VO Hammertoe Implant System (Wright Medical) K120165 - Intraosseous Fixation System (Ortho Helix Surgical Designs, Inc.) K073674 - Kirschner Wires (…
Orthohelix Surgical Designs, Inc.2012—
*K073674Bone Fixation Wire (Kirschner Wire)
Summary page 1
…t System (Wright Medical) K120165 - Intraosseous Fixation System (Ortho Helix Surgical Designs, Inc.) K073674 - Kirschner Wires (Signal Medical Corn.) K061 164 - Activalin " Pin (Bioretec Ltd.)…
Signal Medical Corp.2008—
*K061164Activapin
Summary page 1
…Fixation System (Ortho Helix Surgical Designs, Inc.) K073674 - Kirschner Wires (Signal Medical Corn.) K061 164 - Activalin " Pin (Bioretec Ltd.) K07 1498 - Subtalar Implant (Biomet Sports Medicine)…
Bioretec, Ltd.2006—
*K071498Subtalar Implant
Summary page 1
…K073674 - Kirschner Wires (Signal Medical Corn.) K061 164 - Activalin " Pin (Bioretec Ltd.) K07 1498 - Subtalar Implant (Biomet Sports Medicine) K 120449 - Healix ADVANCETM PEEK Anchor (Depuy Mite…
Biomet Sports Medicine, Inc.20077
*K120449Healix Advance Peek Anchor
Summary page 1
…K061 164 - Activalin " Pin (Bioretec Ltd.) K07 1498 - Subtalar Implant (Biomet Sports Medicine) K 120449 - Healix ADVANCETM PEEK Anchor (Depuy Mitek) Device Description The HammerFiX device is a bone fixation device con…
Depuy Mitek2012—

Also cleared against K120645: 6 other devices →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516
K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165
K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194
K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203
K152710HammerFiX DeviceExtremity Medical, LLC20151
K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151
K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200
K191424Interphalangeal Joint Fusion Device RangeNeosteo20190
K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140

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 24 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
  • 3 of the 27 ancestors have a recall of any class.
  • Of its descendants, K141857 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) has gone furthest, with 16 descendants of its own.
  • 6 other devices also cite its predicate K120645.

How does its category compare?

All HWC devices

HWC 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

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 HammerFiX device 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 K120645

6 other devices cite the same predicate.

  • K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc. · 2017
  • K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  • K141937Trident Fusion ImplantVilex IN Tennessee, Inc. · 2014
  • K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 20142 recalls
  • K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
  • K132895WMT Implantable K-WireWrightmedicaltechnologyinc · 2013

More from Extremity Medical, LLC

28 FDA decisions under this applicant name. See the company

  • K250536MetaFore Small Screw SystemExtremity Medical, LLC · 2025
  • K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  • K211261Axis Charcot Fixation SystemExtremity Medical, LLC · 2021

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K133636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133636: Extremity Medical Hammertoe Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133636

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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