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 Aug 20, 2012 as substantially equivalent to K091614 (Osteomed LP, 2009) after a 96-day review. Its family tree reaches back 1 generation to 2009. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 20, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091614 (2009). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK091614 Osteomed Foot Plating SystemOsteomed LP · 2009
- This deviceK121452 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK172178 Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK123525 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK130964 Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd. · 2017 · cites it directly4descendants
- K123525Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · cites it directly4descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · 2 generations on3descendants
- K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · cites it directly3descendants
- K130964Gridlock Plating SystemTrilliant Surgical, Ltd. · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091614 | Osteomed Foot Plating System | Osteomed LP | 2009 | — |
| 0 (this device) | K121452 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2012 | — |
| +1 | K172178 | Minimally Invasive Bunion Plating System | Trilliant Surgical, Ltd. | 2017 | — |
| +1 | K123525 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2013 | 1 |
| +2 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +1 | K160177 | Gridlock Ankle Plating System | Trilliant Surgical, Ltd. | 2016 | 1 |
| +1 | K130964 | Gridlock Plating System | Trilliant Surgical, Ltd. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K091614 | Osteomed Foot Plating SystemSummary page 1…FR section 888.3030 / 888.3040 Device panel: Orthopedic Legally Marketed Predicate Device: OsteoMed Foot Plating System - K091614 Submitter: Trilliant Surgical LTD 602 Sawyer Street, Suite 120… | 2009 |
What descends from it? (11)
See all 114 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)
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. |
| Aug 6, 2015 | Class II | Z-2490-2015 | Nonconforming Material/Component | The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to… |
| Jul 31, 2015 | Class II | Z-2738-2015 | Component design/selection | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw… |
| Jul 20, 2015 | Class II | Z-2456-2015 | Component design/selection | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 and screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121452: 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/K121452
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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