510(k) · Cleared
ClearedArthrex Mesh 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 Sep 1, 2017 as substantially equivalent to K111253 (Arthrex, Inc., 2011) and 1 other predicate after a 189-day review. Its family tree reaches back 8 generations to 2000. 15 later devices descend from it.
- Decided
- Sep 1, 2017
- Review
- 189 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K000684 (2000). 34 ancestors in all, the oldest K890939 (1989). 15 later devices descend from it, 3 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 deviceK170547 Arthrex Mesh Plate SystemArthrex, Inc. · 2017
- Descendant · cites it directly · 11 of its ownK201132 Arthrex Compression ScrewsArthrex, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK254215 Arthrex Beaming SystemArthrex, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK243195 Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K201132Arthrex Compression ScrewsArthrex, Inc. · 2020 · cites it directly11descendants
- K201677Arthrex Mesh PlatesArthrex, Inc. · 2020 · cites it directly2descendants
- K254215Arthrex Beaming SystemArthrex, Inc. · 2026 · 2 generations on1descendant
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
- K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2025 · 2 generations on1descendant
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) | K170547 | Arthrex Mesh Plate System | Arthrex, Inc. | 2017 | — |
| +1 | K201132 | Arthrex Compression Screws | Arthrex, Inc. | 2020 | — |
| +1 | K201677 | Arthrex Mesh Plates | Arthrex, Inc. | 2020 | — |
| +2 | K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +2 | K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2025 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K111253 | Arthrex Distal Extremity Plate SystemSummary page 5…tallic bone fixation appliances and CFR accessories, 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K111253: Arthrex Distal Extremity Plate System K143614: Arthrex Low Profile Screws Reference Predicate K1… | 2011 |
| * | K143614 | Arthrex Low Profile ScrewsSummary page 5…s, 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K111253: Arthrex Distal Extremity Plate System K143614: Arthrex Low Profile Screws Reference Predicate K150456: Arthrex Plates, Screws, and Staples Purpose of Submission This… | 2015 |
| † | K150456 | Arthrex Plates, Screws, and Staples | 2015 |
What descends from it? (15)
See all 153 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 17 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 34 ancestors have a recall of any class.
- Of its descendants, K201132 (Arthrex, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 9 other devices also cite its predicate K111253.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Mesh Plate 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.
The Arthrex Low Profile Screws (3.0 mm, solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Mesh Plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170547: Arthrex Mesh 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/K170547
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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