510(k) · Cleared
ClearedArthrex Fracture Plates
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 Apr 5, 2013 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 4 other predicates after a 170-day review. Its family tree reaches back 9 generations to 2000. 71 later devices descend from it.
- Decided
- Apr 5, 2013
- Review
- 170 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K000684 (2000). 74 ancestors in all, the oldest K792022 (1979). 71 later devices descend from it, 14 citing it directly.
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations between
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- This deviceK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · cites it directly · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- Descendant · cites it directly · 23 of its ownK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- Descendant · cites it directly · 21 of its ownK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- Descendant · cites it directly · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
- Descendant · 2 generations on · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 3 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 2 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 1 generation backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- This deviceK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · cites it directly38descendants
- K141478Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · cites it directly23descendants
- K151732Arthrex Fracture PlatesArthrex, Inc. · 2015 · cites it directly21descendants
- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · cites it directly15descendants
- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −8 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −7 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −6 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −5 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −4 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −3 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −2 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −1 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +1 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| +1 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| +1 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| +1 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
| +2 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 2…us, femur and fibula. Substantial Equivalence Fracture Plates are substantially equivalent to the predicate Summary Synthes One-Third Tubular Plates (KO011335), Acumed Congruent Bone Plate (1(102998), and the cleared Low Pro… | 2001 |
| * | K102998 | Congruent Bone Plate SystemSummary page 1…ation fastener PredicateDevice KO] 1335: Synthes On-third Tubular Plates K102998: Aewned Congruent Bone Plate Systemn K! 03 70S/K1112S3/K11243 7: Low Profile Screw… | 2011 |
| * | K103705 | Low Profile ScrewsSummary page 2…rd Tubular Plates (KO011335), Acumed Congruent Bone Plate (1(102998), and the cleared Low Profile Screws (K103705, KI 11253, and KI 12437) in which the basic features and intended uses are the same. Any… | 2011 |
| * | K111253 | Arthrex Distal Extremity Plate System | 2011 |
| * | K112437 | Arthrex Fracture SystemSummary page 1…On-third Tubular Plates K102998: Aewned Congruent Bone Plate Systemn K! 03 70S/K1112S3/K11243 7: Low Profile Screw Purpose Of Submission This traditional 510(k) prenwket notification is submitted to… | 2011 |
What descends from it? (71)
See all 7114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141735 | Arthrex Ankle Fusion Plating System | 2014 | 38 |
| K141478 | Arthrex Fracture Plates and Screws | 2014 | 23 |
| K151732 | Arthrex Fracture Plates | 2015 | 21 |
| K170518 | In2Bones Fracture and Correction System | 2017 | 15 |
| K171808 | TDM Plate and Screw System | 2018 | 6 |
| K230546 | Signex | 2024 | 2 |
| K260390 | Super Upper Limbs Versalock Plating System | 2026 | 1 |
| K243740 | Versalock Upper Limb Plating System | 2025 | 1 |
| K242998 | GMReis Ankle Plating System | 2024 | 1 |
| K222244 | Arthrex 3.5 mm Locking Compression Plates | 2022 | 1 |
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.
- 12 of the 74 ancestors have a recall of any class.
- Of its descendants, K141735 (Arthrex, Inc., 2014) has gone furthest, with 38 descendants of its own.
- 42 other devices also cite its predicate K011335.
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 Fracture Plates are 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, 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 bone fixation for bone fractures, fusions, osteotomies and non-unions…
Read the full statement (256 words)
The Arthrex Fracture Plates are 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, 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 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, 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 bone 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 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/K123241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123241: Arthrex Fracture Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123241
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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