510(k) · Cleared
Recalled · Class II · 2022Flexfusion (TM) Fixation Implant
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 Mar 17, 2011 as substantially equivalent to K050259 (Arthrex, Inc., 2005) and 3 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1996. 16 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 17, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 3 generations to K960385 (1996). 7 ancestors in all. 16 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- This deviceK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011
- Descendant · cites it directly · 9 of its ownK122031 Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012
- Descendant · cites it directly · 4 of its ownK130859 Hammertoe Correction SystemArthrosurface, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
- Descendant · cites it directly · 2 of its ownK133515 Peek Fusion ImplantMtp Solutions, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK213530 Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012 · cites it directly9descendants
- K130859Hammertoe Correction SystemArthrosurface, Inc. · 2013 · cites it directly4descendants
- K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · cites it directly3descendants
- K133515Peek Fusion ImplantMtp Solutions, LLC · 2014 · cites it directly2descendants
- K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| 0 (this device) | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | — |
| +1 | K122031 | Nextra TI Hammertoe Correction System | Nextremity Solutions, LLC | 2012 | — |
| +1 | K130859 | Hammertoe Correction System | Arthrosurface, Inc. | 2013 | — |
| +1 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
| +1 | K133515 | Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
| +2 | K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021 | 2 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 22.3 · 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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 1…Arthrex, Inc. Arthrex Blo-Pin (Marketed as Arthrex Trim-ltTM Spin Pin) [510(k) K050259] Pioneer Surgical Technology StayFuseTM Fixation implant [5 10(k) Number K990804] New… | 2005 |
| * | K990804 | StayfuseSummary page 1…n) [510(k) K050259] Pioneer Surgical Technology StayFuseTM Fixation implant [5 10(k) Number K990804] NewDeal SA NEWDEAL K Wire [50 1(k) K022599] Memometal Technologies,… | 1999 |
| * | K022599 | Newdeal K WireSummary page 1…xation implant [5 10(k) Number K990804] NewDeal SA NEWDEAL K Wire [50 1(k) K022599] Memometal Technologies, Inc. Memometal Intramedullary Arthrodesis Device [5 10(k… | 2002 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 1…[50 1(k) K022599] Memometal Technologies, Inc. Memometal Intramedullary Arthrodesis Device [5 10(k) K070598] Description The Nextremity Solutions 3.4mm FlexFusionTM Fixation implant system consists of a two-part 3.4mm di… | 2007 |
What descends from it? (16)
See all 165 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 |
|---|---|---|---|---|
| Feb 10, 2022 | Class II | Z-0912-2022 | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Feb 10, 2022 | Class II | Z-0910-2022 | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Feb 10, 2022 | Class II | Z-0911-2022 | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Feb 10, 2022 | Class II | Z-0913-2022 | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Feb 10, 2022 | Class II | Z-0914-2022 | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Feb 12, 2020 | Class II | Z-1458-2020 | Under Investigation by firm | Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K122031 (Nextremity Solutions, LLC, 2012) has gone furthest, with 9 descendants of its own.
- 15 other devices also cite its predicate K050259.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 FiexFusionTM Fixation Implant 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/K110445 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110445: Flexfusion (TM) Fixation Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110445
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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