510(k) · Cleared
ClearedArsenal Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical · HRS Plate, Fixation, Bone
Cleared on Aug 12, 2019 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) and 3 other predicates after a 118-day review. Its family tree reaches back 15 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 12, 2019
- Review
- 118 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K962616 (1996). 110 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 2 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 1 generation backK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
- This deviceK191009 Arsenal Plating SystemTrilliant Surgical · 2019
- Descendant · cites it directly · 0 of its ownK212378 Arsenal Ankle Plating SystemTrilliant Surgical · 2022
- Descendant · cites it directly · 0 of its ownK200062 Foot and Ankle SystemLeith Medical, LLC · 2021
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 5 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 4 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 3 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 2 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 1 generation backK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
- This deviceK191009 Arsenal Plating SystemTrilliant Surgical · 2019
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 |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −5 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −4 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −3 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −2 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −1 | K160177 | Gridlock Ankle Plating System | Trilliant Surgical, Ltd. | 2016 | 1 |
| 0 (this device) | K191009 | Arsenal Plating System | Trilliant Surgical | 2019 | — |
| +1 | K212378 | Arsenal Ankle Plating System | Trilliant Surgical | 2022 | — |
| +1 | K200062 | Foot and Ankle System | Leith Medical, LLC | 2021 | — |
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 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K983495 | Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…Summary page 4…rthopedic (Primary Predicate) Non-sterile Bone Plate and Screw Implants (Syntec-Taichung Medical Instruments, K983495, HRS & HWC) ExtremiLOCK Foot Plating System (Osteomed, K131445, HRS) Predicate Devices… | 1998 |
| * | K131445 | Osteomed Extremilock Foot Plating SystemSummary page 4…Implants (Syntec-Taichung Medical Instruments, K983495, HRS & HWC) ExtremiLOCK Foot Plating System (Osteomed, K131445, HRS) Predicate Devices Gridlock Ankle Plating System (Trilliant Surgical, K160177, HRS &… | 2013 |
| * | K160177 | Gridlock Ankle Plating SystemSummary page 4…ExtremiLOCK Foot Plating System (Osteomed, K131445, HRS) Predicate Devices Gridlock Ankle Plating System (Trilliant Surgical, K160177, HRS & HWC) Gridlock Plating System (Trilliant Surgical, K130964, HRS… | 2016 |
| * | K130964 | Gridlock Plating SystemSummary page 4…ck Ankle Plating System (Trilliant Surgical, K160177, HRS & HWC) Gridlock Plating System (Trilliant Surgical, K130964, HRS & HWC) II. DEVICE DESCRIPTION The Arsenal Plating System consists of plates of various shapes and sizes compo… | 2013 |
What descends from it? (2)
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 23 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 110 ancestors have a recall of any class.
- Of its descendants, K212378 (Trilliant Surgical, 2022) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K983495.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191009: Arsenal Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191009
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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