510(k) · Cleared
ClearedArthrex Mesh 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 2, 2020 as substantially equivalent to K170547 (Arthrex, Inc., 2017) and 1 other predicate after a 75-day review. Its family tree reaches back 12 generations to 1996. 2 later devices descend from it.
- Decided
- Sep 2, 2020
- Review
- 75 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K962616 (1996). 101 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 1 generation backK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
- This deviceK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203834 Arthrex Patella SuturePlatesArthrex, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK240487 EVOS Patella PlatesSmith & Nephew · 2024
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 1 generation backK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
- This deviceK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −2 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −1 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K201677 | Arthrex Mesh Plates | Arthrex, Inc. | 2020 | — |
| +1 | K203834 | Arthrex Patella SuturePlates | Arthrex, Inc. | 2021 | — |
| +2 | K240487 | EVOS Patella Plates | Smith & Nephew | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K170547 | Arthrex Mesh Plate SystemSummary page 4…Name 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Predicate Device K170547: Arthrex Mesh Plate System (Primary Predicate) K143702: Arthrex Blunt Tip Screws with FiberTape (Secondary… | 2017 |
| * | K143702 | Arthrex Blunt Tip Screws with Fiber TapeSummary page 4…liances and accessories Regulatory Class II Predicate Device K170547: Arthrex Mesh Plate System (Primary Predicate) K143702: Arthrex Blunt Tip Screws with FiberTape (Secondary Predicate) Purpose of This Traditional 510(k) premarket notificati… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203834 | Arthrex Patella SuturePlates | 2021 | 1 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 22 of the 101 ancestors have a recall of any class.
- Of its descendants, K203834 (Arthrex, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K170547.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Plates are 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, osteopenic bone and patella fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201677: Arthrex Mesh Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201677
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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