510(k) · Cleared
ClearedNextra TI Hammertoe Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, LLC · HWC Screw, Fixation, Bone
Cleared on Oct 9, 2012 as substantially equivalent to K110445 (Nextremity Solutions, LLC, 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1996. 9 later devices descend from it.
- Decided
- Oct 9, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960385 (1996). 8 ancestors in all. 9 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 2 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 1 generation backK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- This deviceK122031 Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012
- Descendant · cites it directly · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK213530 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK142478 opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica) · 2015
- Descendant · 3 generations on · 0 of its ownK221610 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK211996 Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · cites it directly3descendants
- K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · 2 generations on1descendant
- K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica) · 2015 · cites it directly1descendant
- K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2022 · 3 generations on0descendants
- K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −3 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −2 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −1 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| 0 (this device) | K122031 | Nextra TI Hammertoe Correction System | Nextremity Solutions, LLC | 2012 | — |
| +1 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
| +2 | K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021 | 2 |
| +1 | K142478 | opti-Toe | Graham Medical Technologies, LLC (D.B.A.Gramedica) | 2015 | — |
| +3 | K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2022 | — |
| +2 | K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K110445 | Flexfusion (TM) Fixation ImplantSummary page 1…ct code: HWC - Class 11 Predicate Devices Nextremity Solutions, LLC FlexFusionTM Fixation implant [510(k) K110445] Arthrex, Inc. Arthrex Bio-Pin (Marketed as Arthrex T… | 2011 |
| * | K050259 | Arthrex Bio-PinSummary page 1…Arthrex Bio-Pin (Marketed as Arthrex Trin-ItTm Spin Pin) [5 10(k) K050259] Description The Nextremity Solutions NextrTm Ti Hammertoe Correction (Nextra) System consists of proximal and distal- componen… | 2005 |
What descends from it? (9)
5 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 16 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K200840 (Nextremity Solutions, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K110445.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Nextraim Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122031: Nextra TI Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122031
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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