510(k) · Cleared
Recalled · Class II · 2022DuoHex CH Cannulated Hammertoe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 26, 2020 as substantially equivalent to K122031 (Nextremity Solutions, LLC, 2012) and 2 other predicates after an 87-day review. Its family tree reaches back 8 generations to 2002. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 26, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K013888 (2002). 27 ancestors in all, the oldest K954330 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 7 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 6 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 5 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 4 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- 3 generations backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- 2 generations backK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- 1 generation backK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- This deviceK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK213530 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK221610 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211996 Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · cites it directly1descendant
- K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022 · 2 generations on0descendants
- K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −7 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −6 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −5 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −4 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| −3 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | — |
| +1 | K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021 | 2 |
| +2 | K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2022 | — |
| +1 | K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122031 | Nextra TI Hammertoe Correction SystemSummary page 4…Class II Product Code: HWC-primary product code, NDL Substantially Equivalent Devices: • Nextremity Solutions, Nextra Ti Hammertoe Correction System, K122031-Primary Predicate • Nextremity Solutions, Nextra Hammertoe Correction System (Cleared as FlexFusion Fixation S… | 2012 |
| * | K110445 | Flexfusion (TM) Fixation ImplantSummary page 4…ertoe Correction System, K122031-Primary Predicate • Nextremity Solutions, Nextra Hammertoe Correction System (Cleared as FlexFusion Fixation System), K110445- Additional Predicate • Wright Medical Technology, Inc PHALINX Hammertoe System, K150252- Additional Predicate Device… | 2011 |
| * | K150252 | PHALINX Hammertoe SystemSummary page 4…Hammertoe Correction System (Cleared as FlexFusion Fixation System), K110445- Additional Predicate • Wright Medical Technology, Inc PHALINX Hammertoe System, K150252- Additional Predicate Device Description: The DuoHexTM CH Cannulated Hammertoe System consists of a two-part cannulated bo… | 2015 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2022 | Class II | Z-0739-2022 | Device Design | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ… |
| Jan 13, 2022 | Class II | Z-0740-2022 | Device Design | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K213530 (Nextremity Solutions, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K122031.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Nextremity Solutions DuoHex™ CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
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/K200840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200840: DuoHex CH Cannulated 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/K200840
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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