510(k) · Cleared
ClearedPro-Toe Hammertoe Fixation 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 Mar 7, 2014 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 3 other predicates after a 44-day review. Its family tree reaches back 5 generations to 2002. 20 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 44 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K013888 (2002). 15 ancestors in all, the oldest K954330 (1995). 20 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 4 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 3 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 2 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 1 generation backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- This deviceK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 6 of its ownK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- Descendant · cites it directly · 4 of its ownK151838 PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- 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
- K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −4 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −3 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −2 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −1 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| 0 (this device) | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| +1 | K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
| +2 | K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101165 | Pro-Toe VO Hammertow Implant System | 2010 |
| * | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionSummary page 1…KIOI 165 - PRO-TOETM VO Hanmmertoe Implant System K1 20645 -PRO-TOETM Hammertoe Implant System… | 2012 |
| * | K122959 | Hammer Toe ImplantSummary page 1…K1 20645 -PRO-TOETM Hammertoe Implant System K122959 - Trilliant Hammer Toe Implant K1 32895 - WMT Implantable K-Wires (a)(4). Devi… | 2012 |
| * | K132895 | WMT Implantable K-WireSummary page 1…System K122959 - Trilliant Hammer Toe Implant K1 32895 - WMT Implantable K-Wires (a)(4). Device Description The PRO-TOE® Hammetoe Fixation System is composed of implants and instr… | 2013 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142585 | PhaLinx Hammertoe System | 2014 | 9 |
| K150252 | PHALINX Hammertoe System | 2015 | 6 |
| K151838 | PRO-TOE Hammertoe Fixation System | 2015 | 4 |
| K170326 | dynaMX Intramedullary Implant | 2017 | 2 |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | 2022 | 0 |
| K141714 | Pro-Toe X-Flex Hammertoe Fixation System | 2014 | 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 12 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K142585 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 9 descendants of its own.
- 13 other devices also cite its predicate K101165.
How does its category compare?
All HWC devicesHWC 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
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® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone fractures…
Read the full statement (109 words)
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The 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, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140148: Pro-Toe Hammertoe Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140148
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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