510(k) · Cleared
ClearedTrigon 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, Inc. · PLF Bone Wedge
Cleared on Dec 21, 2020 as substantially equivalent to K193414 (Nvision Biomedical Technologies, Inc., 2020) after a 28-day review. Its family tree reaches back 15 generations to 1996. 5 later devices descend from it.
- Decided
- Dec 21, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K954385 (1996). 134 ancestors in all, the oldest K810258 (1981). 5 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- 2 generations backK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- 1 generation backK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- This deviceK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
- Descendant · 2 generations on · 0 of its ownK234116 Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024
- Descendant · cites it directly · 0 of its ownK223226 Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 6 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 5 generations backK141905 Pro-Link Wedge SystemLife Spine · 2014
- 4 generations backK150368 Tarsa-Link Wedge Fixation SystemLife Spine · 2015
- 3 generations backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- 2 generations backK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- 1 generation backK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- This deviceK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · cites it directly4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 2 generations on1descendant
- K252254Osteotomy Wedge SystemSinaptic Surgical · 2025 · 3 generations on0descendants
- K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024 · 2 generations on0descendants
- K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −6 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −5 | K141905 | Pro-Link Wedge System | Life Spine | 2014 | — |
| −4 | K150368 | Tarsa-Link Wedge Fixation System | Life Spine | 2015 | — |
| −3 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | 2016 | — |
| −2 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019 | — |
| −1 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| 0 (this device) | 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 | — |
| +2 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +3 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
| +2 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024 | — |
| +1 | K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
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 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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.
What descends from it? (5)
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 24 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 48 of the 134 ancestors have a recall of any class.
- Of its descendants, K220197 (Nvision Biomedical Technologies, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K193414.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203445: Trigon HA Stand-Alone Wedge Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203445
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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