510(k) · Cleared
Recalled · Class II · 2020Arthrex Fracture Plates and Screws
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 8, 2014 as substantially equivalent to K123241 (Arthrex, Inc., 2013) and 1 other predicate after a 34-day review. Its family tree reaches back 10 generations to 2000. 23 later devices descend from it. It has been recalled once.
- Decided
- Jul 8, 2014
- Review
- 34 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K000684 (2000). 75 ancestors in all, the oldest K792022 (1979). 23 later devices descend from it, 3 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 deviceK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014
- Descendant · cites it directly · 21 of its ownK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- Descendant · 2 generations on · 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 · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 2 generations on · 2 of its ownK203294 Arthrex Pilon Fusion SystemArthrex, Inc. · 2021
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 deviceK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K151732Arthrex Fracture PlatesArthrex, Inc. · 2015 · cites it directly21descendants
- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · 2 generations on11descendants
- K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018 · cites it directly6descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
- K203294Arthrex Pilon Fusion SystemArthrex, Inc. · 2021 · 2 generations on2descendants
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) | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | — |
| +1 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| +2 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +1 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +2 | K203294 | Arthrex Pilon Fusion System | Arthrex, Inc. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 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? (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 |
|---|---|---|---|
| * | K123241 | Arthrex Fracture PlatesSummary page 1…rex Fracture Plates and Screws, which were cleared as non-sterile devices through K123241. This special 510(k) premarket notification is also intended… | 2013 |
| * | K103705 | Low Profile ScrewsSummary page 1…fixation fastener Prediate Dvice 123241: Arthrex Fracture Plates _______ K103 705: Arthrex Low Profile Screws Purpose ofSubmission This special 510(k) premarket notification is submitted to… | 2011 |
What descends from it? (23)
See all 233 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2020 | Class II | Z-2733-2020 | Process control | Screws provided in packaging are 5mm shorter 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, K151732 (Arthrex, Inc., 2015) has gone furthest, with 21 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 Fracture Plates are intended to be used for internal bane fixation far bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula. 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 bane fixation for bone fractures, fusions, osteotomies, and…
Read the full statement (257 words)
The Arthrex Fracture Plates are intended to be used for internal bane fixation far bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
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 bane 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, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bane fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
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, 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 bane 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/K141478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141478: Arthrex Fracture Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141478
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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