510(k) · Cleared
ClearedArthrex 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 Jul 3, 2013 as substantially equivalent to K040022 (Stryker Leibinger, 2004) and 4 other predicates after a 42-day review. Its family tree reaches back 8 generations to 2000. 20 later devices descend from it.
- Decided
- Jul 3, 2013
- Review
- 42 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K000684 (2000). 47 ancestors in all, the oldest K885250 (1989). 20 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 2 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 1 generation backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- This deviceK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK254215 Arthrex Beaming SystemArthrex, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · cites it directly11descendants
- K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · cites it directly6descendants
- K143749Arthrex Distal Radius SystemArthrex, Inc. · 2015 · cites it directly2descendants
- K254215Arthrex Beaming SystemArthrex, Inc. · 2026 · 2 generations on1descendant
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −4 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −3 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −1 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
| +1 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +1 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| +1 | K143749 | Arthrex Distal Radius System | Arthrex, Inc. | 2015 | — |
| +2 | K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 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 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 1…*Smooth or threaded metallic bone fixation fastener *21 dFR 888.3040 Predicate Device K040022 / K(1002 71: Stryker VariAx Distal Radius Locking Plate System… | 2004 |
| * | K100271 | Vari AX Distal Radius Line Extensions of XXL Plates | 2010 |
| * | K123875 | Aap Radius Set 2.5Summary page 1…redicate Device K040022 / K(1002 71: Stryker VariAx Distal Radius Locking Plate System ?K123875: ap Radius Set K(103705/111253: Low Profile Screws Purpse… | 2013 |
| * | K103705 | Low Profile ScrewsSummary page 1…adius Locking Plate System ?K123875: ap Radius Set K(103705/111253: Low Profile Screws Purpse o Subissin *This traditional 510(k) premarket no… | 2011 |
| * | K111253 | Arthrex Distal Extremity Plate SystemSummary page 1…ocking Plate System ?K123875: ap Radius Set K(103705/111253: Low Profile Screws Purpse o Subissin *This traditional 510(k) premarket notificat… | 2011 |
What descends from it? (20)
See all 204 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 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 47 ancestors have a recall of any class.
- Of its descendants, K201132 (Arthrex, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 11 other devices also cite its predicate K040022.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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…
Read the full statement (285 words)
The Arthrex 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 (2.0-2.4mm 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.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.7mm 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, Distal Radius Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131474: Arthrex Distal Radius Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131474
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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