510(k) · Cleared
ClearedArthrex Distal Extremity Plate System
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 Aug 2, 2011 as substantially equivalent to K090692 (Wrightmedicaltechnologyinc, 2009) and 3 other predicates after a 90-day review. Its family tree reaches back 7 generations to 2000. 135 later devices descend from it.
- Decided
- Aug 2, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K000684 (2000). 32 ancestors in all, the oldest K890939 (1989). 135 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · cites it directly · 91 of its ownK112437 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 · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 2 generations on · 23 of its ownK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · cites it directly91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · cites it directly71descendants
- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 2 generations on38descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
- K141478Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +1 | 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 |
| +1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 11 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 10 | 0 |
| 2026 | 23 | 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? (4)
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 |
|---|---|---|---|
| * | K090692 | Ortholoc 2.0/2.4 Plate SystemSummary page 1…21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener. Predicate Device K090692: Wright Ortholoc 2.0/2.4 Plate System K063049: Synthes Modular Mini Fragment LCP… | 2009 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 1…fastener. Predicate Device K090692: Wright Ortholoc 2.0/2.4 Plate System K063049: Synthes Modular Mini Fragment LCP System K050110: Synthes Modular Foot System… | 2006 |
| * | K050110 | Synthes (Usa) LCP Modular Foot PlatesSummary page 1…2.0/2.4 Plate System K063049: Synthes Modular Mini Fragment LCP System K050110: Synthes Modular Foot System K103705: Arthrex Low Profile Screws Pu… | 2005 |
| * | K103705 | Low Profile ScrewsSummary page 1…s Modular Mini Fragment LCP System K050110: Synthes Modular Foot System K103705: Arthrex Low Profile Screws Purpose of Submission This traditional 510(k) premarket notification is su… | 2011 |
What descends from it? (135)
See all 13510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112437 | Arthrex Fracture System | 2011 | 91 |
| K123241 | Arthrex Fracture Plates | 2013 | 71 |
| K140397 | Paralock Plating System / Tuffnek Screw | 2014 | 31 |
| K131474 | Arthrex Distal Radius Plate System | 2013 | 20 |
| K170547 | Arthrex Mesh Plate System | 2017 | 15 |
| K201132 | Arthrex Compression Screws | 2020 | 11 |
| K150456 | Arthrex Plates, Screws, and Staples | 2015 | 6 |
| K122334 | Checkmate Small Bone Fusion System | 2012 | 5 |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | 2026 | 0 |
| K201235 | Arthrex MaxForce MTP Compression Plates and Screws | 2020 | 0 |
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.
- 10 of the 32 ancestors have a recall of any class.
- Of its descendants, K112437 (Arthrex, Inc., 2011) has gone furthest, with 91 descendants of its own.
- 9 other devices also cite its predicate K090692.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Distal Extremity Plate System is intended for use in stabilization of
fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of
small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111253: Arthrex Distal Extremity Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111253
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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