510(k) · Cleared
ClearedArthrex Minimally Invasive Ankle Fusion Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 16, 2019 as substantially equivalent to K141735 (Arthrex, Inc., 2014) after a 188-day review. Its family tree reaches back 11 generations to 2000. 1 later device descends from it.
- Decided
- Oct 16, 2019
- Review
- 188 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K000684 (2000). 76 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations between
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK190953 Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK202307 Activ FuseNewclip Technics · 2020
Show all 11 generations
- Root · 11 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 10 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 9 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 8 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 7 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 6 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 5 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 4 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 3 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 2 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 1 generation backK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- This deviceK190953 Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K202307Activ FuseNewclip Technics · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −10 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −9 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −8 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −7 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −6 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −5 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −4 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −1 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| 0 (this device) | K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | Arthrex, Inc. | 2019 | — |
| +1 | K202307 | Activ Fuse | Newclip Technics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 4…and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K141735: Arthrex Ankle Fusion Plating System K040907: Arthrex Small Fragment Plates and Screws (Reference)… | 2014 |
| † | K040907 | Arthrex Small Fragment Plates and Screws | 2004 |
| † | K150456 | Arthrex Plates, Screws, and Staples | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202307 | Activ Fuse | 2020 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 76 ancestors have a recall of any class.
- Of its descendants, K202307 (Newclip Technics, 2020) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K141735.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Arthrex Minimally Invasive Ankle Fusion Plate is intended to be used for fixation of bone fractures and fusions in the foot and ankle. The Arthrex Minimally Invasive Ankle Fusion Plate is to be used with the Arthrex Low Profile Screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190953: Arthrex Minimally Invasive Ankle Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190953
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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