510(k) · Cleared
ClearedAlignX Ankle Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extremity Medical, LLC · HRS Plate, Fixation, Bone
Cleared on May 23, 2018 as substantially equivalent to K160191 (Extremity Medical, LLC, 2016) and 3 other predicates after a 30-day review. Its family tree reaches back 14 generations to 1996. 4 later devices descend from it.
- Decided
- May 23, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K954385 (1996). 217 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 1 generation backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- This deviceK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- Descendant · cites it directly · 1 of its ownK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
- Descendant · cites it directly · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK252246 Leforte MMF SystemJeil Medical Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK221362 Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022
Show all 14 generations
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 6 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 5 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 1 generation backK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- This deviceK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023 · cites it directly1descendant
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · cites it directly1descendant
- K252246Leforte MMF SystemJeil Medical Corporation · 2026 · 2 generations on0descendants
- K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −13 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −12 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −11 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −10 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −9 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −8 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −7 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −6 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −5 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −1 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | — |
| 0 (this device) | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| +1 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | — |
| +1 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +2 | K252246 | Leforte MMF System | Jeil Medical Corporation | 2026 | — |
| +2 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 16 | 0 |
| 1997 | 5 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 12 | 0 |
| 2001 | 20 | 0 |
| 2002 | 18 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K160191 | Align Anterior Ankle Fusion PlateSummary page 4…21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener Number Product Code HRS (plate, fixation, bone); HWC (screw, fixation, bone) K160191 – Extremity Medical Align Ankle Fusion Plate Predicate K141735 – Arthrex Ankle Fusion Plating System Devices K1… | 2016 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 4…mber Product Code HRS (plate, fixation, bone); HWC (screw, fixation, bone) K160191 – Extremity Medical Align Ankle Fusion Plate Predicate K141735 – Arthrex Ankle Fusion Plating System Devices K132591 – WMT Maxlock Extreme K133691 – Osteomed Exremi… | 2014 |
| * | K132591 | Maxlock Extreme SystemSummary page 4…fixation, bone) K160191 – Extremity Medical Align Ankle Fusion Plate Predicate K141735 – Arthrex Ankle Fusion Plating System Devices K132591 – WMT Maxlock Extreme K133691 – Osteomed Exremilock The AlignX Ankle Fusion System is a bone… | 2013 |
| * | K133691 | Extrimilock Ankle Plating SystemSummary page 4…remity Medical Align Ankle Fusion Plate Predicate K141735 – Arthrex Ankle Fusion Plating System Devices K132591 – WMT Maxlock Extreme K133691 – Osteomed Exremilock The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical,… | 2014 |
What descends from it? (4)
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)
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 22 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 33 of the 217 ancestors have a recall of any class.
- Of its descendants, K231887 (Jeil Medical Corporation, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
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/K181067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181067: AlignX Ankle Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181067
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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