510(k) · Cleared
ClearedArthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
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, 2019 as substantially equivalent to K063049 (Synthes (Usa), 2006) after a 136-day review. Its family tree reaches back 1 generation to 2006. 8 later devices descend from it.
- Decided
- Oct 3, 2019
- Review
- 136 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063049 (2006). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK063049 Synthes (Usa) Modular Mini Fragment LCP SystemSynthes (Usa) · 2006 · Recalled
- This deviceK191344 Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleArthrex, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · cites it directly · 2 of its ownK220937 Arthrex Mini Fragment SystemArthrex, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 2 generations on · 1 of its ownK242554 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260809 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210754Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly3descendants
- K220937Arthrex Mini Fragment SystemArthrex, Inc. · 2022 · cites it directly2descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
- K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024 · 2 generations on1descendant
- K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063049 | Synthes (Usa) Modular Mini Fragment LCP System | Synthes (Usa) | 2006 | 4 |
| 0 (this device) | K191344 | Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module | Arthrex, Inc. | 2019 | — |
| +1 | K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +1 | K220937 | Arthrex Mini Fragment System | Arthrex, Inc. | 2022 | — |
| +2 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +2 | K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
| +2 | K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K063049: Synthes (USA) Modular Mini Fragment LCP System Purpose of This Traditional 510(k) premarket notification is submitted… | 2006 |
What descends from it? (8)
3 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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).…
Read the full statement (132 words)
The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).
The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191344: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191344
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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