510(k) · Cleared
ClearedArthrex 2.4 mm Volar Distal Radius Plate 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 Oct 3, 2022 as substantially equivalent to K131474 (Arthrex, Inc., 2013) and 1 other predicate after a 67-day review. Its family tree reaches back 10 generations to 2000. 1 later device descends from it.
- Decided
- Oct 3, 2022
- Review
- 67 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K000684 (2000). 60 ancestors in all, the oldest K885250 (1989). 1 later device descends from it, 1 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 backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 1 generation backK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- This deviceK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243368 Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025
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 backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 1 generation backK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- This deviceK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K243368Montblanc Plate SystemMedifield Medical Co., Ltd. · 2025 · cites it directly0descendants
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 | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
| −1 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | 2022 | — |
| +1 | K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K131474 | Arthrex Distal Radius Plate SystemSummary page 5…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K131474: Arthrex Distal Radius Plate System Additional Predicate Device(s) K150456: Arthrex Plates, Screws and Staples Reference Device… | 2013 |
| * | K150456 | Arthrex Plates, Screws, and StaplesSummary page 5…bone fixation fastener Regulatory Class II Predicate Device K131474: Arthrex Distal Radius Plate System Additional Predicate Device(s) K150456: Arthrex Plates, Screws and Staples Reference Device(s) K203294: Arthrex Pilon Fusion System… | 2015 |
| † | K203294 | Arthrex Pilon Fusion System | 2021 |
| † | K213837 | Arthrx Fracture Plates | 2022 |
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 |
|---|---|---|---|
| K243368 | Montblanc Plate System | 2025 | 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 22 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 14 of the 60 ancestors have a recall of any class.
- Of its descendants, K243368 (Medifield Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131474.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 2.4 mm Volar Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.…
Read the full statement (126 words)
The Arthrex 2.4 mm Volar Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application.
The Arthrex Low Profile Screws (2.4 mm, 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius 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/K222267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222267: Arthrex 2.4 mm Volar Distal Radius Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222267
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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