510(k) · Cleared
ClearedArthrex Compression Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · JDR Staple, Fixation, Bone
Cleared on Feb 13, 2008 as substantially equivalent to K043059 (Wrightmedicaltechnologyinc, 2005) after a 28-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.
- Decided
- Feb 13, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043059 (2005). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043059 Compression Staple and Simple StapleWrightmedicaltechnologyinc · 2005
- This deviceK080111 Arthrex Compression StapleArthrex, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK130510 Arthrex Compression PlatesArthrex, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK262618 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130510Arthrex Compression PlatesArthrex, Inc. · 2013 · cites it directly8descendants
- K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · cites it directly6descendants
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
- K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022 · 2 generations on1descendant
- K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043059 | Compression Staple and Simple Staple | Wrightmedicaltechnologyinc | 2005 | — |
| 0 (this device) | K080111 | Arthrex Compression Staple | Arthrex, Inc. | 2008 | — |
| +1 | K130510 | Arthrex Compression Plates | Arthrex, Inc. | 2013 | — |
| +1 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +2 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | 2022 | — |
| +3 | K262618 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K043059 | Compression Staple and Simple StapleSummary page 1…e component metallic bone fixation *appliances and accessories Predicate Devices Wright Medical Compression Staple, K043059 Device Description and Intended The Arthrex Compression Staple isametal staple offered in U… | 2005 |
What descends from it? (9)
2 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 JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080111 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080111: Arthrex Compression Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080111
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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