510(k) · Cleared
ClearedTrigon™ Ti 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 23, 2019 as substantially equivalent to K151256 (Arthex, Inc., 2015) and 2 other predicates after a 90-day review. Its family tree reaches back 13 generations to 1996. 7 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K954385 (1996). 132 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK141905 Pro-Link Wedge SystemLife Spine · 2014
- 2 generations backK150368 Tarsa-Link Wedge Fixation SystemLife Spine · 2015
- 1 generation backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- This deviceK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 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
Show all 13 generations
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 11 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 10 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 9 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 8 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 7 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 6 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 5 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 4 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK141905 Pro-Link Wedge SystemLife Spine · 2014
- 2 generations backK150368 Tarsa-Link Wedge Fixation SystemLife Spine · 2015
- 1 generation backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- This deviceK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly6descendants
- K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on5descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 2 generations on1descendant
- K252254Osteotomy Wedge SystemSinaptic Surgical · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −12 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −11 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −10 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −9 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −8 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −7 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −6 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −5 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −4 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K141905 | Pro-Link Wedge System | Life Spine | 2014 | — |
| −2 | K150368 | Tarsa-Link Wedge Fixation System | Life Spine | 2015 | — |
| −1 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | 2016 | — |
| 0 (this device) | 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 | — |
| +2 | K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K151256 | Arthrex BioSync® Bone WedgeSummary page 5…Predicate Device Name / Manufacturer Primary Predicate K151256 Arthrex BioSync Wedge System K161037 Life Spine Tarsa-Link Wedge Fi… | 2015 |
| * | K161037 | Tarsa-Link Stand-Alone Wedge Fixation SystemSummary page 5…Predicate K151256 Arthrex BioSync Wedge System K161037 Life Spine Tarsa-Link Wedge Fixation System K140531 Wright Medical Technology BIOFOAM Bone Wedge The followi… | 2016 |
| * | K140531 | Biofoam Bone WedgeSummary page 5…Predicate K151256 Arthrex BioSync Wedge System K161037 Life Spine Tarsa-Link Wedge Fixation System K140531 Wright Medical Technology BIOFOAM Bone Wedge The following reference devices are also cited in this submission: • Nvi… | 2014 |
| † | K182949 | Healix™ Compression Screw System | 2018 |
| † | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | 2017 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | 2020 | 6 |
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 7 companies; a new generation was cleared every 1.4 years on median.
- 48 of the 132 ancestors have a recall of any class.
- Of its descendants, K193414 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K151256.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies
The Trigon Ti wedges are intended for use with ancillary fixation.
The Trigon Ti 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/K192645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192645: Trigon™ Ti 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/K192645
Report an extraction error
Are you the manufacturer?
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