510(k) · Cleared
ClearedArthrex Pilon Fusion 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 Feb 3, 2021 as substantially equivalent to K151732 (Arthrex, Inc., 2015) and 1 other predicate after an 86-day review. Its family tree reaches back 12 generations to 2000. 2 later devices descend from it.
- Decided
- Feb 3, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K000684 (2000). 78 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations between
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK203294 Arthrex Pilon Fusion SystemArthrex, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK242554 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260809 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 11 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 10 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 9 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 8 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 7 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 6 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 5 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 4 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK203294 Arthrex Pilon Fusion SystemArthrex, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −11 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −10 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −9 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −8 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −7 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −6 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −5 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −4 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −1 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K203294 | Arthrex Pilon Fusion System | Arthrex, Inc. | 2021 | — |
| +1 | K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
| +1 | K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026 | — |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K151732 | Arthrex Fracture PlatesSummary page 6…nces and accessories, 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener; Class II Regulatory Class II Predicate Device K151732: Arthrex Fracture Plates (Primary Predicate) K141735: Arthrex Ankle Fusion Plating System (Additional Predi… | 2015 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 6…bone fixation fastener; Class II Regulatory Class II Predicate Device K151732: Arthrex Fracture Plates (Primary Predicate) K141735: Arthrex Ankle Fusion Plating System (Additional Predicate) Purpose of This Traditional 510(k) premarket notification… | 2014 |
What descends from it? (2)
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 21 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 78 ancestors have a recall of any class.
- Of its descendants, K242554 (Arthrex, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K151732.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Pilon Fusion Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous. The Arthrex Low Profile Screws (3.5mm 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…
Read the full statement (108 words)
The Arthrex Pilon Fusion Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.
The Arthrex Low Profile Screws (3.5mm 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 and Osteotomy Plates.
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/K203294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203294: Arthrex Pilon 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/K203294
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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