510(k) · Cleared
Recalled · Class II · 2018Gridlock Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · HRS Plate, Fixation, Bone
Cleared on Feb 15, 2013 as substantially equivalent to K121452 (Trilliant Surgical, Ltd., 2012) and 1 other predicate after a 92-day review. Its family tree reaches back 2 generations to 2009. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 15, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K091614 (2009). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK091614 Osteomed Foot Plating SystemOsteomed LP · 2009
- 1 generation backK121452 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2012 · Recalled
- This deviceK123525 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK130964 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK191009 Arsenal Plating SystemTrilliant Surgical · 2019
- Descendant · 3 generations on · 0 of its ownK212378 Arsenal Ankle Plating SystemTrilliant Surgical · 2022
- Descendant · 3 generations on · 0 of its ownK200062 Foot and Ankle SystemLeith Medical, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K130964Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · cites it directly3descendants
- K191009Arsenal Plating SystemTrilliant Surgical · 2019 · 2 generations on2descendants
- K212378Arsenal Ankle Plating SystemTrilliant Surgical · 2022 · 3 generations on0descendants
- K200062Foot and Ankle SystemLeith Medical, LLC · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091614 | Osteomed Foot Plating System | Osteomed LP | 2009 | — |
| −1 | K121452 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2012 | 4 |
| 0 (this device) | K123525 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2013 | — |
| +1 | K130964 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2013 | 1 |
| +2 | K191009 | Arsenal Plating System | Trilliant Surgical | 2019 | — |
| +3 | K212378 | Arsenal Ankle Plating System | Trilliant Surgical | 2022 | — |
| +3 | K200062 | Foot and Ankle System | Leith Medical, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K121452 | Gridlock Plating SystemSummary page 1…CIFR section: 21 CFR section 888.3030 / 888.3040 Device panel: OrthopedicOrthopedic Legally Marketed Gridlock Plating System (K121452) Predicate Device: OsteoMed Foot Plating System (K(091614) Submitter: Trilliant Surgic… | 2012 |
| * | K091614 | Osteomed Foot Plating SystemSummary page 1…vice panel: OrthopedicOrthopedic Legally Marketed Gridlock Plating System (K121452) Predicate Device: OsteoMed Foot Plating System (K(091614) Submitter: Trilliant Surgical LTD 6721 Portwest Dr, Suite 160… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130964 | Gridlock Plating System | 2013 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2018 | Class II | Z-1609-2020 | Labeling Change Control | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K130964 (Trilliant Surgical, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K121452.
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 Gridlock 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 (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123525: Gridlock 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/K123525
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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