510(k) · Cleared
ClearedArthrex Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTN Washer, Bolt Nut
Cleared on Dec 21, 2011 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 4 other predicates after a 119-day review. Its family tree reaches back 8 generations to 2000. 91 later devices descend from it.
- Decided
- Dec 21, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K000684 (2000). 72 ancestors in all, the oldest K792022 (1979). 91 later devices descend from it, 6 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 deviceK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · cites it directly · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · 2 generations on · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 23 of its ownK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 21 of its ownK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- Descendant · 2 generations on · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · cites it directly71descendants
- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 2 generations on38descendants
- K141478Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · 2 generations on23descendants
- K151732Arthrex Fracture PlatesArthrex, Inc. · 2015 · 2 generations on21descendants
- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · 2 generations on15descendants
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) | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +1 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +2 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| +2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| +2 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| +2 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 19 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL Plate | 2001 |
| Kept off the family tree | K102998 | FDA’s K102998 is Congruent Bone Plate System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…ce KO1 1335: Synthes One-Third Tubular Plates K10299&- Acumed Congruent Bone Plate System K043248/K052 776- Arthrex TightRope Syndesmosis and Acromi~oclavicular (AC) Devices… | 2005 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 1…335: Synthes One-Third Tubular Plates K10299&- Acumed Congruent Bone Plate System K043248/K052 776- Arthrex TightRope Syndesmosis and Acromi~oclavicular (AC) Devices… | 2005 |
| * | K103705 | Low Profile ScrewsSummary page 2…Syndesmosis and Acromioclavicular (AC) Devices (K043248 / K052776), and the cleared Arthrex Low Profile Screws (K 103705, KI 11253) in which the basic features and intended uses are the same. Any differences between the Frac… | 2011 |
| * | K111253 | Arthrex Distal Extremity Plate System | 2011 |
What descends from it? (91)
See all 916 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 11 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 72 ancestors have a recall of any class.
- Of its descendants, K123241 (Arthrex, Inc., 2013) has gone furthest, with 71 descendants of its own.
- 42 other devices also cite its predicate K011335.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Arthrex Fracture Syvstem is intended to be used for internal bone fixation for bone fraictures, fusions, osteotomies and non-unions in the ankle, foot hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.Omm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for th& treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112437: Arthrex Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112437
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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