510(k) · Cleared
ClearedTrigon Trigon HA Stand-Alone Wedge Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies · PLF Bone Wedge
Cleared on Jan 26, 2024 as substantially equivalent to K220197 (Nvision Biomedical Technologies, Inc., 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Jan 26, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K954385 (1996). 145 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 2 generations backK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 1 generation backK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- This deviceK234116 Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024
Show all 17 generations
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 15 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 14 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 13 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 12 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 11 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 10 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 9 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 8 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK141905 Pro-Link Wedge SystemLife Spine · 2014
- 6 generations backK150368 Tarsa-Link Wedge Fixation SystemLife Spine · 2015
- 5 generations backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- 4 generations backK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- 3 generations backK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 2 generations backK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 1 generation backK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- This deviceK234116 Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −16 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −15 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −14 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −13 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −12 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −11 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −10 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −9 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −8 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K141905 | Pro-Link Wedge System | Life Spine | 2014 | — |
| −6 | K150368 | Tarsa-Link Wedge Fixation System | Life Spine | 2015 | — |
| −5 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | 2016 | — |
| −4 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019 | — |
| −3 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| −2 | K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| −1 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| 0 (this device) | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 PLF? 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 PLF device
- #1 K193414 Trigon HA Stand-Alone Wedge Fixation Systemscore 17.8 · 14 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 |
|---|---|---|---|
| * | K220197 | Trigon HA Wedge Fixation SystemSummary page 5…s: 510(k) Number Predicate Device Name / Manufacturer Predicate Nvision Biomedical’s Trigon™ HA Stand-Alone Wedge K220197 Primary Fixation System… | 2022 |
| * | K193414 | Trigon HA Stand-Alone Wedge Fixation SystemSummary page 5…Primary Fixation System Nvision Biomedical’s Trigon™ HA Stand-Alone Wedge K193414 Additional Fixation System Nvis… | 2020 |
| † | K193645 | nva, nvp, and nvt | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 48 of the 145 ancestors have a recall of any class.
- 2 other devices also cite its predicate K220197.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PLF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLF
30in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLF
2in 2025
MAUDE reports naming product code PLF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 3 | 30 | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton (opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
• Z-Calcaneal Lengthening Osteotomies
• MTP Lengthening Arthrodesis
The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234116: Trigon Trigon HA Stand-Alone Wedge Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234116
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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