510(k) · Cleared
ClearedArthrex Compression 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 Sep 25, 2013 as substantially equivalent to K052614 (Arthrex, Inc., 2005) and 2 other predicates after a 210-day review. Its family tree reaches back 6 generations to 2000. 8 later devices descend from it.
- Decided
- Sep 25, 2013
- Review
- 210 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000684 (2000). 16 ancestors in all, the oldest K890939 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- This deviceK130510 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
- Descendant · 2 generations on · 0 of its ownK252807 Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −2 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −1 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K052614 | Low Profile Plate and Screw SystemSummary page 1…Name 21 CER 888.8030: Single/multiple component metallic bone fixation CFR appliances and accessonies Predicate Device K052614. Art/irex Low Profile Plate and Screw System K040907.: Art/vex Smnall Fragment Plates and Scre… | 2005 |
| * | K040907 | Arthrex Small Fragment Plates and ScrewsSummary page 1…CFR appliances and accessonies Predicate Device K052614. Art/irex Low Profile Plate and Screw System K040907.: Art/vex Smnall Fragment Plates and Screws K080OI I.-Art/ire Compression Staple P… | 2004 |
| * | K080111 | Arthrex Compression Staple Our reading of the summary gave K080011, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arthrex Compression Staple”. | 2008 |
What descends from it? (8)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K150456 (Arthrex, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 12 other devices also cite its predicate K052614.
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 Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130510: Arthrex Compression Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130510
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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