510(k) · Cleared
ClearedPhaLinx Hammertoe 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 Nov 20, 2014 as substantially equivalent to K113006 (Orthopro, LLC, 2012) and 3 other predicates after a 66-day review. Its family tree reaches back 6 generations to 2002. 9 later devices descend from it.
- Decided
- Nov 20, 2014
- Review
- 66 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K013888 (2002). 20 ancestors in all, the oldest K954330 (1995). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 5 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 4 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 3 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 2 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- 1 generation backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- This deviceK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 6 of its ownK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK213530 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 0 of its ownK221610 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK212996 Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015 · cites it directly6descendants
- K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · 2 generations on3descendants
- K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · 3 generations on1descendant
- K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022 · 4 generations on0descendants
- K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −5 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −4 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −3 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −2 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| −1 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
| +3 | K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021 | 2 |
| +4 | K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2022 | — |
| +2 | K212996 | Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K113006 | I-Fuse Hammer Toe SystemsSummary page 4…nce: 21 CFR 888.3040 – Class II Device Product Code, Device Panel: HWC – Orthopedic (a)(3). Predicate Device: K113006: I-Fuse Hammer Toe Systems K022599: NEWDEAL® K WIRE… | 2012 |
| * | K022599 | Newdeal K WireSummary page 4…HWC – Orthopedic (a)(3). Predicate Device: K113006: I-Fuse Hammer Toe Systems K022599: NEWDEAL® K WIRE K132895 & K140148: WMT Implantable K-… | 2002 |
| * | K132895 | WMT Implantable K-WireSummary page 4…K113006: I-Fuse Hammer Toe Systems K022599: NEWDEAL® K WIRE K132895 & K140148: WMT Implantable K- Wires (a)(4). Device Description The P… | 2013 |
| * | K140148 | Pro-Toe Hammertoe Fixation SystemSummary page 4…6: I-Fuse Hammer Toe Systems K022599: NEWDEAL® K WIRE K132895 & K140148: WMT Implantable K- Wires (a)(4). Device Description The PhaLinx® Ha… | 2014 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K150252 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K113006.
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 PhaLinx® Hammertoe System is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142585: PhaLinx Hammertoe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142585
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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