510(k) · Cleared
Recalled · Class II · 2019Arthrex Ankle Fusion Plating System
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 Aug 15, 2014 as substantially equivalent to K123241 (Arthrex, Inc., 2013) after a 49-day review. Its family tree reaches back 10 generations to 2000. 38 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K000684 (2000). 75 ancestors in all, the oldest K792022 (1979). 38 later devices descend from it, 12 citing it directly.
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations between
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 1 generation backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- This deviceK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014
- Descendant · cites it directly · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK182361 Arthrex Compression FT ScrewsArthrex, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- Descendant · cites it directly · 3 of its ownK182148 SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 9 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 8 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 7 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 6 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 5 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 4 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 1 generation backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- This deviceK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · cites it directly11descendants
- K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018 · cites it directly6descendants
- K182361Arthrex Compression FT ScrewsArthrex, Inc. · 2018 · cites it directly4descendants
- K181067AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018 · cites it directly4descendants
- K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −9 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −8 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −7 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −6 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −5 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −4 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −1 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | — |
| +1 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +1 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +1 | K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018 | — |
| +1 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| +1 | K182148 | SILVERBACK Gorilla Plating System | Paragon 28, Inc. | 2018 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K123241 | Arthrex Fracture PlatesSummary page 5…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K123241: Arthrex Fracture Plates Purpose of Submission This special 510(k) premarket not… | 2013 |
What descends from it? (38)
See all 3812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201132 | Arthrex Compression Screws | 2020 | 11 |
| K171808 | TDM Plate and Screw System | 2018 | 6 |
| K182361 | Arthrex Compression FT Screws | 2018 | 4 |
| K181067 | AlignX Ankle Fusion System | 2018 | 4 |
| K182148 | SILVERBACK Gorilla Plating System | 2018 | 3 |
| K203294 | Arthrex Pilon Fusion System | 2021 | 2 |
| K173121 | Ankle Fusion Plating System | 2017 | 2 |
| K231887 | ARIX Ankle Distal Tibia System | 2023 | 1 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2019 | Class II | Z-1510-2020 | Employee error | Screws provided in the device package are 6 mm longer than intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 75 ancestors have a recall of any class.
- Of its descendants, K201132 (Arthrex, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 13 other devices also cite its predicate K123241.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula. The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions…
Read the full statement (122 words)
The Arthrex Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141735: Arthrex Ankle Fusion Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141735
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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